Collection of Blood From Patients With Cancer

Breast Cancer Clinical Trial

Official title: Biospecimen Acquisition From Human Subjects

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Prostate Cancer

• NCT number: NCT00034216
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Sheri A McMahon, R.N.
• Phone: (240) 760-7968
• Email: sheri.mcmahon@nih.gov
• Status: Recruiting
• Start date: July 16, 2002