Cell collection study paves way for future cancer therapies
NCT ID NCT00068003
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 8 times
Summary
This study collects white blood cells and tumor cells from cancer patients, and white blood cells from healthy volunteers, to help researchers grow anti-cancer cells in the lab. The goal is to create experimental cell therapies for future use. Up to 7,000 participants will provide samples, but no direct treatment is given in this study.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 7,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2003
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients with a current diagnosis of cancer who are 18 years of age or older - Healthy volunteers who are 18 years of age or older and meet the safety evaluation criteria established by the FDA for donation of blood products, or, meet the safety evaluation criteria established by the NIH Clinical Center Department of Transfusion Medicine (DTM) Blood Bank for screening of allogeneic whole blood donors
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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.
* ELIGIBILITY CRITERIA FOR PATIENTS WITH A CURRENT DIAGNOSIS OF CANCER: INCLUSION CRITERIA: * Patients must have a form of cancer currently being studied in the NCI-SB. * Patient is able to understand and willing to sign a written informed consent document. * Age greater than or equal to 18 years. * Clinical performance status of ECOG 0 or 1. * Serology * Seronegative for HIV antibody. (The experimental treatments being evaluated depend upon an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities). * Seronegative for hepatitis B surface antigen and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. * Lesions which will be harvested for the generation of TIL should be accessible via standard surgical or radiological techniques and be associated with acceptable morbidity. EXCLUSION CRITERIA: * Active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular, respiratory, or immune system. * Patients who cannot give proper informed consent to the experimental therapy due to an active psychiatric disorder or inability to understand the nature of the proposed therapy and attendant risk. * Women of child-bearing potential who are pregnant because of the potentially dangerous effects of some of the procedures (e.g., tumor biopsy or surgery for tumor resection) on the fetus. ELIGIBILITY CRITERIA FOR HEALTHY VOLUNTEERS: INCLUSION CRITERIA for PBMC Donors: * Age greater than or equal to 18 years. * Non-reactive for HBsAg, anti-HBc, anti-HCV, anti-HIV-1/2, HBV/HCV/HIV-1 NAT, anti-HTLV-I/II, anti-T. cruzi, West Nile Virus NAT,syphilis, and babesia. * PBMC donors must meet the strict behavioral and medical history requirements as per applicable NCI-SB Apheresis Donor SOP(s). INCLUSION CRITERIA FOR WHOLE BLOOD DONORS: * Age greater than or equal to 18 years. * Whole blood donors must meet the DTM inclusion criteria for allogeneic whole blood donation. EXCLUSION CRITERIA for PBMC Donors: * Has had babesiosis. * Is at risk or has Creutzfeldt-Jakob Disease. * Is on steroid therapy or any other medication or has received vaccination that might interfere with cell preparation per Principal Investigator s (PI) discretion. * Has ongoing illness that would cause harm to the volunteer during the apheresis procedure as determined by the PI. * Has had yellow jaundice, liver disease, or hepatitis since the age of 11. * Has uncontrolled diabetes. * Has a hematologic malignancy or any bleeding abnormalities. * Has received any type of organ transplant in the past 12 months. * Has undergone xenotransplantation at any time. * Has received a dura mater graft. * If female, is pregnant or has given birth within the last six weeks. * Has had an ear or body piercing or tattoos within the past 12 months. * Has had a blood transfusion within the past 12 months. * Has spent time outside the United States to a restricted country. * Has participated in any high-risk activities. EXCLUSION CRITERIA for Whole Blood Donors: \- Whole blood donors who do not meet the DTM criteria for allogeneic whole blood donation.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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