Blood test could revolutionize sarcoma monitoring
NCT ID NCT06068075
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a liquid biopsy (a blood test that detects tumor DNA) can help predict outcomes for people with Ewing sarcoma or osteosarcoma. Researchers will collect blood samples from 340 patients at diagnosis and track their health over time. The goal is to see if the amount of tumor DNA in the blood can tell doctors how aggressive the cancer is and how well treatment is working.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Liquid biopsy (FoundationOne Liquid CDx test)
- What this could lead to
- If successful, this could lead to a simple blood test that helps doctors predict how aggressive a sarcoma is and whether treatment is working, without needing repeated tissue biopsies.
- What could go wrong
- This is an observational study, not a treatment trial. The test may not prove accurate enough to change patient care, and results may not apply to all sarcoma types or stages.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 340 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2018
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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12 months to 50 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: * For Part A, subjects must meet all of the following eligibility criteria. * Age: ≥ 12 months of age at time of study enrollment to 50 years of age * Diagnosis: Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed, localized or regionally disseminated Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) of bone or soft tissue or; Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed, non-pelvic, localized or regionally disseminated high-grade osteosarcoma. NOTE: Staging will be assessed according to standard of care at the treating center. * Prior Therapy: * Patients should have only previously had a biopsy, and not had prior attempt at tumor resection. * Not yet started chemotherapy or radiation therapy OR patient has started chemotherapy or radiation therapy, but an appropriate pre-treatment baseline sample was collected and processed for ctDNA under a local banking study in DFCI Pediatrics and is available to use for this study. * Planned to receive chemotherapy as follows: \-- VDC/IE as per COG protocols AEWS0031, AEWS1031 or AEWS1221 (for patients with Ewing sarcoma or PNET); or MAP as per COG protocol AOST0331 (for patients with osteosarcoma). * For Part B subjects must meet all of the following eligibility criteria. * Age: ≥ 12 months of age at time of study enrollment * Diagnosis: Patients with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) of bone or soft tissue * Prior Therapy: * Patients should have had only frontline therapy as per institutional standard, and maintenance therapy if given (no relapse therapy). * If frontline systemic therapy already completed (not including maintenance or metastatic site radiation), therapy completed within 6 months of enrollment to Part B. * Subjects must have a willing physician provider supporting their participation in Part B. * For Part B, providers are eligible to receive the provider survey if they are listed as the primary provider for the patient at the study site. Exclusion Criteria: * For Part A, subjects must not meet any of the following exclusion criteria. * Patients with distant metastatic disease. * Patients with known Ewing-like sarcoma (e.g., BCOR-CCNB3 or CIC-DUX4 translocated small round cell sarcomas) are not eligible. * Patients who are enrolled with an initial diagnosis of Ewing sarcoma and subsequently found to have Ewing-like sarcoma will be replaced. Samples obtained prior to removal from study will be analyzed and reported descriptively. Patients with Ewing-like tumors may continue to provide samples and clinical data until they meet off-study criteria per protocol. * Patients weighing \< 5 kg at time of diagnosis * Patients with a second malignant neoplasm * Patients without detectable tumor at the time of study enrollment (ie, complete tumor resection prior to study enrollment) * Patients already receiving tumor-directed therapy at the time of study enrollment except when a pre-treatment baseline sample has already been obtained under a local banking study in DFCI Pediatrics that would be eligible for analysis under this study. * Patients with osteosarcoma with a pelvic primary tumor site Pregnancy * For Part B, subjects must not meet any of the following exclusion criteria. * Patients with known Ewing-like sarcoma (e.g., BCOR-CCNB3 or CIC-DUX4 translocated small round cell sarcomas) are not eligible. * Samples obtained prior to removal from study will be analyzed and reported descriptively. Patients with Ewing-like tumors may continue to provide samples and clinical data until they meet off-study criteria per protocol * Patients weighing \< 5 kg at time of enrollment * Patients diagnosed with relapsed disease and/or having started therapy directed at disease relapse * Pregnancy * Resides outside of the United States * For Part B, providers at non-study centers will not be eligible to receive the provider survey.
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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.
Contacts and locations
Locations
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Boston Children's Hospital
Boston, Massachusetts, 02115, United States
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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Children's Hospital's and Clinics of Minnesota
Minneapolis, Minnesota, 55404, United States
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Childrens Hospital Los Angeles
Los Angeles, California, 90027-0700, United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
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Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
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Lifespan / Rhode Island Hospital
Providence, Rhode Island, 02903, United States
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
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Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
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Seattle Children's Hospital
Seattle, Washington, 98105, United States
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St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
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University of Utah Childrens Medical Center
Salt Lake City, Utah, 84113, United States
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Other studies related to the condition(s) this trial covers.
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