An observational study in Prostate Cancer, Breast Cancer and Colon Cancer, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by National Cancer Institute (NCI) · Observational
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment.
Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their condition, patients may be invited to enroll in a clinical research study involving chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during the course of treatment.
Background:
Objectives:
Eligibility:
Design:
- Cases will be evaluated by NCI or Interventional Radiology, NIH Clinical Center personnel. Blood, tissue, urine, saliva or other samples may be collected at the initial visit and at follow-up visits.
Primary clinical; healthy volunteers may include NIH employees
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 This content is being retained for historical reference.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.
Healthy volunteers 18 years of age and older
Participants with cancer 18 years of age and older
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Time frame: ongoing
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
Time frame: ongoing
Collection of tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
Analyze tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
Time frame: ongoing
Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting information: Study protocol, Sap, Icf
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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National Cancer Institute (NCI)