Collection of Blood From Patients With Cancer

Trial Title: Collection of Blood From Patients With Cancer

NCT ID: NCT00034216

Condition: Prostate Cancer
Breast Cancer
Colon Cancer
Lung Cancer
Liver Cancer

Conditions: Official terms:
Liver Neoplasms

Conditions: Keywords:
Suppressor Cells
T-cells
CD4+ / CD25+ cells
Natural History
Cancer
Malignancy
Blood Sample

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Summary: 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.

Detailed description: Background: - Correlative studies performed on biospecimens of human subjects can be used to investigate the biology of solid tumors, inform the development of new strategies for treating those cancers, and evaluate these new therapeutic approaches. Specific areas of interest include, but are not limited to: - the underlying mechanisms of tumor-specific immune response and suppression in cancer patients - genetic and molecular profiling of tumors through circulating tumor cell (cTC), circulating DNA, and tissue analysis - investigation of potential early diagnostic and prognostic indicators for solid tumors such as cTCs and miRNA expression of serum exosomes - identification of mechanisms of drug-related adverse events and correlation with clinical parameters - the role of commensal gut microbiota in both the innate and adaptive responses to tumors as well as with the use of anticancer agents Objectives: - Analyze biospecimens such as tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects. - Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes. - Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis. Eligibility: - Patients and healthy volunteers whose biospecimens are of interest to NIH investigators. - 18 years of age or older. 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.

Criteria for eligibility:

Study pop:
Primary clinical; healthy volunteers may include NIH employees

Sampling method: Non-Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: National Institutes of Health Clinical Center

Address:
City: Bethesda
Zip: 20892
Country: United States

Status: Recruiting

Contact:
Last name: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Phone: 888-624-1937

Start date: July 16, 2002

Lead sponsor:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: National Institutes of Health Clinical Center (CC)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00034216
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2002-C-0179.html