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Collection of Blood From Patients With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) Identifier:
First received: April 24, 2002
Last updated: December 1, 2016
Last verified: September 2016

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.

Prostate Cancer
Breast Cancer
Colon Cancer
Lung Cancer
Liver Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Biospecimen Acquisition From Human Subjects

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Analyze tissue, urine, saliva, and blood components, which include serum, leukocytes, and circulating tumor cells (cTC), of human subjects. [ Time Frame: On-going ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Undertake genetic analysis of both procariotic and eucariotic samples for advanced mutational analysis. [ Time Frame: On-going ] [ Designated as safety issue: No ]
  • Analyze normal and/or tumor serum and tissue samples to identify mechanisms of drug related adverse events, and correlate these with treatment toxicity and clinical parameters. [ Time Frame: On-going ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: April 2002
Detailed Description:


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


  • 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 year 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.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.


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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00034216

Contact: Sheri A McMahon, R.N. (301) 496-9812
Contact: James L Gulley, M.D. (301) 480-7164

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: James L Gulley, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00034216     History of Changes
Other Study ID Numbers: 020179  02-C-0179 
Study First Received: April 24, 2002
Last Updated: December 1, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Suppressor Cells
CD4+/CD25+ Cells
Blood Sample

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on December 02, 2016