Could less radiation be enough? new trial hopes to reduce side effects for kids with brain tumors
NCT ID NCT06368817
First seen Jun 25, 2026 · Last updated Aug 26, 2026 · Updated 5 times
Summary
This phase II trial is testing whether giving a lower dose of radiation after chemotherapy can effectively treat children and young adults with central nervous system germinomas, a type of brain tumor. The study will enroll 240 participants aged 3 to 29. After initial chemotherapy with carboplatin and etoposide, patients receive either proton or 3D conformal radiation at a reduced dose based on how well the tumor responded. The goal is to maintain high cure rates while minimizing long-term side effects from radiation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Carboplatin and Etoposide chemotherapy followed by reduced-dose proton or 3D conformal radiation therapy
- What this could lead to
- If successful, this could mean children with CNS germinomas can receive lower radiation doses, reducing long-term side effects while still controlling the disease.
- What could go wrong
- This is a phase II trial, so it is still testing whether the lower radiation dose is as effective as the standard dose. There is a risk that the reduced radiation may not control the tumor as well, leading to recurrence.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Nov 2033
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 to 29 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must be ≥ 3 years and \< 30 years at the time of study enrollment * Patients must be newly-diagnosed primary localized germinoma of the suprasellar and/or pineal region by pathology and/or serum and/or CSF hCGbeta 5-50 mIU/mL AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists), including tumors with contiguous ventricular or unifocal parenchymal extension. No histologic confirmation required * Patients with EITHER (A) bifocal (pineal + suprasellar) involvement OR (B) pineal lesion with diabetes insipidus (DI) AND hCGbeta ≤ 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. No histologic confirmation required * Patients with hCGbeta 51-100 mIU/mL in serum and/or CSF and institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. Histologic confirmation of germinoma IS required * Patients with germinoma of the basal ganglia and or/thalamic primary sites are eligible * Patients with metastatic germinoma including non-contiguous disease or distant disease in the brain, ventricles, or spine are eligible * Patients with germinoma admixed with mature teratoma are eligible * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age * Patients must have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1-CNS * Imaging studies must be obtained within 31 days prior to study enrollment and start of protocol therapy. (Note: for patients that have had surgery and post-operative imaging performed, it is the post-operative MRI that must be obtained within 31 days prior to enrollment.) * Patients must have a cranial magnetic resonance imaging (MRI) with and without gadolinium at diagnosis/prior to enrollment. If surgical resection is performed, patients must have pre-operative and post-operative brain MRI with and without gadolinium. The post-operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required * Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment * Patients must be enrolled, and protocol therapy must begin, no later than 31 days after definitive surgery or clinical diagnosis, whichever is later * Patients must have eligibility confirmed by Rapid Central Tumor Marker Review performed on APEC14B1-CNS * Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at least 10 days following surgery and prior to study enrollment. False positive cytology can occur within 10 days of surgery. Of note, lumbar CSF should not be performed prior to obtaining spine MRI, as this can make interpretation of the spine MRI less clear * Patients must have CSF tumor markers obtained prior to study enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred. In case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first. Ideally serum and CSF tumor markers should be collected at the same time and processed without delay * For patients with solid tumors: Peripheral absolute neutrophil count (ANC) \>= 1000/uL (Must be performed within 7 days prior to enrollment unless otherwise indicated) * For patients with solid tumors: Platelet count \>= 100,000/uL (transfusion independent) (Must be performed within 7 days prior to enrollment unless otherwise indicated) * For patients with solid tumors: Hemoglobin \>= 8.0 g/dL (may receive red blood cell \[RBC\] transfusions) (Must be performed within 7 days prior to enrollment unless otherwise indicated) * For pediatric patients (age 3-17 years): A serum creatinine based on age/sex as follows (Must be performed within 7 days prior to enrollment unless otherwise indicated): * Age: 3 to \< 6 years; maximum serum creatinine (mg/dL): 0.8 (male); 0.8 (female) * Age: 6 to \< 10 years; maximum serum creatinine (mg/dL): 1 (male); 1 (female) * Age: 10 to \< 13 years; maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female) * Age: 13 to \< 16 years; maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female) * Age: ≥ 17 years; maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female) OR a 24-hour urine creatinine clearance ≥ 70 mL/min/1.73 m\^2 OR a glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard). * Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility. * For adult patients (age 18 years or older) (Must be performed within 7 days prior to enrollment unless otherwise indicated): * Creatinine clearance ≥ 70 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (Must be performed within 7 days prior to enrollment unless otherwise indicated) * Serum glutamic-pyruvic transaminase (SGPT) (alanine transaminase \[ALT\]) ≤ 135 U/L (Must be performed within 7 days prior to enrollment unless otherwise indicated) * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L * No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled * CNS toxicity =\< grade 2 * Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load are eligible for this study Exclusion Criteria: * Patients with any of the following malignant pathological elements are not eligible: * Endodermal sinus (yolk sac) * Embryonal carcinoma, choriocarcinoma * Malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some germinoma) * Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible * Patients who have received any prior tumor-directed therapy for their diagnosis of germinoma other than surgical intervention and corticosteroids are not eligible * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential. * Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards * Lactating females who plan to breastfeed their infants * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Basal ganglia germinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
114 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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Albany Medical Center
RECRUITINGAlbany, New York, 12208, United States
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Alfred I duPont Hospital for Children
RECRUITINGWilmington, Delaware, 19803, United States
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Alliance for Childhood Diseases/Cure 4 the Kids Foundation
RECRUITINGLas Vegas, Nevada, 89135, United States
Contact Email: •••••@•••••
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Arkansas Children's Hospital
RECRUITINGLittle Rock, Arkansas, 72202-3591, United States
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Arnold Palmer Hospital for Children
RECRUITINGOrlando, Florida, 32806, United States
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BI-LO Charities Children's Cancer Center
RECRUITINGGreenville, South Carolina, 29605, United States
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Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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British Columbia Children's Hospital
RECRUITINGVancouver, British Columbia, V6H 3V4, Canada
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C S Mott Children's Hospital
RECRUITINGAnn Arbor, Michigan, 48109, United States
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CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
RECRUITINGQuébec, G1V 4G2, Canada
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CancerCare Manitoba
RECRUITINGWinnipeg, Manitoba, R3E 0V9, Canada
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Cardinal Glennon Children's Medical Center
RECRUITINGSt Louis, Missouri, 63104, United States
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Centre Hospitalier Universitaire Sainte-Justine
RECRUITINGMontreal, Quebec, H3T 1C5, Canada
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Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
RECRUITINGSherbrooke, Quebec, J1H 5N4, Canada
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Children's Healthcare of Atlanta - Arthur M Blank Hospital
RECRUITINGAtlanta, Georgia, 30329, United States
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Children's Hospital
RECRUITINGLondon, Ontario, N6A 5W9, Canada
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Children's Hospital Colorado
RECRUITINGAurora, Colorado, 80045, United States
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Children's Hospital Los Angeles
RECRUITINGLos Angeles, California, 90027, United States
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Children's Hospital and Medical Center of Omaha
RECRUITINGOmaha, Nebraska, 68114, United States
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Children's Hospital of Orange County
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
Contact Email: •••••@•••••
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Children's Hospital of Pittsburgh of UPMC
RECRUITINGPittsburgh, Pennsylvania, 15224, United States
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Children's Hospital of San Antonio
RECRUITINGSan Antonio, Texas, 78207, United States
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Children's Hospital of The King's Daughters
RECRUITINGNorfolk, Virginia, 23507, United States
Contact Email: •••••@•••••
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Children's Hospitals and Clinics of Minnesota - Minneapolis
RECRUITINGMinneapolis, Minnesota, 55404, United States
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Children's Mercy Hospitals and Clinics
RECRUITINGKansas City, Missouri, 64108, United States
Contact Email: •••••@•••••
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Children's National Medical Center
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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Connecticut Children's Medical Center
RECRUITINGHartford, Connecticut, 06106, United States
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Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
RECRUITINGGrand Rapids, Michigan, 49503, United States
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITINGLebanon, New Hampshire, 03756, United States
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Dell Children's Medical Center of Central Texas
RECRUITINGAustin, Texas, 78723, United States
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Driscoll Children's Hospital
RECRUITINGCorpus Christi, Texas, 78411, United States
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East Tennessee Childrens Hospital
RECRUITINGKnoxville, Tennessee, 37916, United States
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Hackensack University Medical Center
RECRUITINGHackensack, New Jersey, 07601, United States
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Hospital for Sick Children
RECRUITINGToronto, Ontario, M5G 1X8, Canada
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IWK Health Centre
RECRUITINGHalifax, Nova Scotia, B3K 6R8, Canada
Contact Email: •••••@•••••
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John Hunter Children's Hospital
RECRUITINGHunter Regional Mail Centre, New South Wales, 2310, Australia
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Johns Hopkins All Children's Hospital
RECRUITINGSt. Petersburg, Florida, 33701, United States
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Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITINGBaltimore, Maryland, 21287, United States
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Kapiolani Medical Center for Women and Children
RECRUITINGHonolulu, Hawaii, 96826, United States
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Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITINGNew York, New York, 10016, United States
Contact Email: •••••@•••••
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Loma Linda University Medical Center
RECRUITINGLoma Linda, California, 92354, United States
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Loyola University Medical Center
RECRUITINGMaywood, Illinois, 60153, United States
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Lucile Packard Children's Hospital Stanford University
RECRUITINGPalo Alto, California, 94304, United States
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Lurie Children's Hospital-Chicago
RECRUITINGChicago, Illinois, 60611, United States
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Maine Children's Cancer Program
RECRUITINGScarborough, Maine, 04074, United States
Contact Email: •••••@•••••
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Massachusetts General Hospital Cancer Center
SUSPENDEDBoston, Massachusetts, 02114, United States
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
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McMaster Children's Hospital at Hamilton Health Sciences
RECRUITINGHamilton, Ontario, L8N 3Z5, Canada
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Medical City Dallas Hospital
RECRUITINGDallas, Texas, 75230, United States
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Memorial Regional Hospital/Joe DiMaggio Children's Hospital
RECRUITINGHollywood, Florida, 33021, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Montefiore Medical Center - Moses Campus
RECRUITINGThe Bronx, New York, 10467, United States
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Mount Sinai Hospital
RECRUITINGNew York, New York, 10029, United States
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NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
RECRUITINGNew York, New York, 10032, United States
Contact Email: •••••@•••••
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Nationwide Children's Hospital
RECRUITINGColumbus, Ohio, 43205, United States
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Nemours Children's Clinic - Pensacola
RECRUITINGPensacola, Florida, 32504, United States
Contact Email: •••••@•••••
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Nemours Children's Clinic-Jacksonville
RECRUITINGJacksonville, Florida, 32207, United States
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Nemours Children's Hospital
RECRUITINGOrlando, Florida, 32827, United States
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Newark Beth Israel Medical Center
RECRUITINGNewark, New Jersey, 07112, United States
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Nicklaus Children's Hospital
RECRUITINGMiami, Florida, 33155, United States
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Norton Children's Hospital
RECRUITINGLouisville, Kentucky, 40202, United States
Contact Email: •••••@•••••
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Oregon Health and Science University
RECRUITINGPortland, Oregon, 97239, United States
Contact Email: •••••@•••••
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Perth Children's Hospital
RECRUITINGPerth, Western Australia, 6009, Australia
Contact Email: •••••@•••••
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Phoenix Childrens Hospital
RECRUITINGPhoenix, Arizona, 85016, United States
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Primary Children's Hospital
RECRUITINGSalt Lake City, Utah, 84113, United States
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Prisma Health Richland Hospital
RECRUITINGColumbia, South Carolina, 29203, United States
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Providence Sacred Heart Medical Center and Children's Hospital
RECRUITINGSpokane, Washington, 99204, United States
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Queensland Children's Hospital
RECRUITINGSouth Brisbane, Queensland, 4101, Australia
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Rady Children's Hospital - San Diego
RECRUITINGSan Diego, California, 92123, United States
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Rainbow Babies and Childrens Hospital
RECRUITINGCleveland, Ohio, 44106, United States
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Rhode Island Hospital
RECRUITINGProvidence, Rhode Island, 02903, United States
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Riley Hospital for Children
RECRUITINGIndianapolis, Indiana, 46202, United States
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Royal Children's Hospital
RECRUITINGParkville, Victoria, 3052, Australia
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Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
RECRUITINGNew Brunswick, New Jersey, 08903, United States
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Sacred Heart Hospital
ACTIVE_NOT_RECRUITINGPensacola, Florida, 32504, United States
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Saint Christopher's Hospital for Children
RECRUITINGPhiladelphia, Pennsylvania, 19134, United States
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Saint Joseph's Hospital/Children's Hospital-Tampa
RECRUITINGTampa, Florida, 33607, United States
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Saint Joseph's Regional Medical Center
RECRUITINGPaterson, New Jersey, 07503, United States
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Saint Jude Children's Research Hospital
RECRUITINGMemphis, Tennessee, 38105, United States
Contact Email: •••••@•••••
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Saint Luke's Cancer Institute - Boise
RECRUITINGBoise, Idaho, 83712, United States
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Saint Peter's University Hospital
RECRUITINGNew Brunswick, New Jersey, 08901, United States
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Sanford Broadway Medical Center
RECRUITINGFargo, North Dakota, 58122, United States
Contact Email: •••••@•••••
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Sanford USD Medical Center - Sioux Falls
RECRUITINGSioux Falls, South Dakota, 57117-5134, United States
Contact Email: •••••@•••••
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Seattle Children's Hospital
RECRUITINGSeattle, Washington, 98105, United States
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State University of New York Upstate Medical University
RECRUITINGSyracuse, New York, 13210, United States
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Summerlin Hospital Medical Center
RECRUITINGLas Vegas, Nevada, 89144, United States
Contact Email: •••••@•••••
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Sydney Children's Hospital
RECRUITINGRandwick, New South Wales, 2031, Australia
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The Children's Hospital at Westmead
RECRUITINGWestmead, New South Wales, 2145, Australia
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The Montreal Children's Hospital of the MUHC
RECRUITINGMontreal, Quebec, H3H 1P3, Canada
Contact Email: •••••@•••••
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The Steven and Alexandra Cohen Children's Medical Center of New York
RECRUITINGNew Hyde Park, New York, 11040, United States
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UCSF Benioff Children's Hospital Oakland
RECRUITINGOakland, California, 94609, United States
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UCSF Medical Center-Mission Bay
RECRUITINGSan Francisco, California, 94158, United States
Contact Email: •••••@•••••
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UNC Lineberger Comprehensive Cancer Center
RECRUITINGChapel Hill, North Carolina, 27599, United States
Contact Email: •••••@•••••
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USA Health Strada Patient Care Center
RECRUITINGMobile, Alabama, 36604, United States
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UT MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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UT Southwestern/Simmons Cancer Center-Dallas
RECRUITINGDallas, Texas, 75390, United States
Contact Email: •••••@•••••
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University of Alberta Hospital
RECRUITINGEdmonton, Alberta, T6G 2B7, Canada
Contact Email: •••••@•••••
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University of Chicago Comprehensive Cancer Center
RECRUITINGChicago, Illinois, 60637, United States
Contact Email: •••••@•••••
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University of Illinois
RECRUITINGChicago, Illinois, 60612, United States
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University of Iowa/Holden Comprehensive Cancer Center
RECRUITINGIowa City, Iowa, 52242, United States
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University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITINGMiami, Florida, 33136, United States
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University of Minnesota/Masonic Cancer Center
RECRUITINGMinneapolis, Minnesota, 55455, United States
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University of Mississippi Medical Center
RECRUITINGJackson, Mississippi, 39216, United States
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University of Nebraska Medical Center
RECRUITINGOmaha, Nebraska, 68198, United States
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University of Oklahoma Health Sciences Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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University of Texas Health Science Center at San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
Contact Email: •••••@•••••
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University of Virginia Cancer Center
RECRUITINGCharlottesville, Virginia, 22908, United States
Contact Email: •••••@•••••
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University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITINGMadison, Wisconsin, 53792, United States
Contact Email: •••••@•••••
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Vanderbilt University/Ingram Cancer Center
RECRUITINGNashville, Tennessee, 37232, United States
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Wake Forest University Health Sciences
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
Contact Email: •••••@•••••
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Women's and Children's Hospital-Adelaide
RECRUITINGNorth Adelaide, South Australia, 5006, Australia
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Yale University
RECRUITINGNew Haven, Connecticut, 06520, United States
Contact Email: •••••@•••••
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