Collecting blood samples from cancer patients
Biospecimen Acquisition From Human Subjects
This study is collecting blood samples from cancer patients to see how their immune cells change before and after chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00034216 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect blood samples from patients with various types of cancer, including prostate, breast, colon, lung, and liver cancer, to analyze immune suppressor cells before and after chemotherapy. Participants, aged 18 and older, will have approximately 50 ml of blood drawn, with additional samples taken during treatment if applicable. The study focuses on understanding the immune response and potential biomarkers related to cancer treatment outcomes, utilizing advanced genetic and molecular profiling techniques.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older with a known or suspected malignancy.
Not a fit: Patients who are not diagnosed with cancer or are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of immune suppression in cancer patients and inform future treatment strategies.
How similar studies have performed: Other studies have shown success in using biospecimen analysis to inform cancer treatment strategies, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible. Performance status of ECOG 0, 1, 2, or 3 for admission to this protocol. Ability to understand and the willingness to sign a written informed consent document. INCLUSION FOR APHERESIS: Note: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference. Hemoglobin greater than or equal to 10 mg/dL and platelet count \> 75,000/mm(3) Weight greater than 25 kg HIV negative Prothrombin Time - within normal limits Partial Thromboplastin Time - within normal limits Medically indicated central line in place or adequate peripheral venous access EXCLUSION CRITERIA: None.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer L Marte — National Cancer Institute (NCI)
- Study coordinator: Michell J Manu, R.N.
- Email: michell.manu@nih.gov
- Phone: (240) 529-3415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.