Collection of Blood From Patients With Cancer

Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Liver Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - 100
Start Date:July 16, 2002
Contact:Sheri A McMahon, R.N.
Phone:(240) 760-7968

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Biospecimen Acquisition From Human Subjects

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.


- 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

- 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


- 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.


- Patients and healthy volunteers whose biospecimens are of interest to NIH investigators.

- 18 years of age or older.


- 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.


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


Effective with Amendment CC, patients 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


Children will not be eligible.
We found this trial at
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: (888) NCI-1937
Bethesda, MD
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