Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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 year of age or older. Design: - Subject 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:

- INCLUSION CRITERIA: Patients 18 years of age and older are eligible. Patients must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol. INCLUSION FOR APHERESIS: 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: Children will not be eligible.


NCT ID:

NCT00034216


Primary Contact:

Principal Investigator
James L Gulley, M.D.
National Cancer Institute (NCI)

Sheri A McMahon, R.N.
Phone: (240) 760-6085
Email: smcmahon@mail.nih.gov


Backup Contact:

Email: gulleyj@mail.nih.gov
James L Gulley, M.D.
Phone: (301) 480-7164


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Phone: (888) NCI-1937

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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