Bethesda, Maryland 20892

  • Liver Cancer


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 years 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.


- 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: Children will not be eligible.



Primary Contact:

Principal Investigator
Jennifer L Marte
National Cancer Institute (NCI)

Sheri A McMahon, R.N.
Phone: (240) 760-7968

Backup Contact:

Jennifer L Marte
Phone: (301) 496-7214

Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Phone: 888-624-1937

Site Status: Recruiting

Data Source:

Date Processed: November 27, 2022

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