Collection of Blood From Patients With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00034216
First received: April 24, 2002
Last updated: May 11, 2016
Last verified: March 2016
  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.


Condition
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:

Background:

  • To date, the underlying mechanisms of tumor-specific immune suppression have not been well understood in cancer patients, nor has the effect of chemotherapy on these been well characterized.
  • cTC analysis potentially provides valuable information regarding the genetic and molecular profile of tumors and may predict progression-free survival (PFS) and overall survival (OS) earlier than the standard evaluation techniques using radiological scans.
  • Profiling of miRNA expression in serum exosomes from healthy controls an cancer patients might be a useful diagnostic test for early cancer detection with non-invasive methods.
  • Microtubule-associated modifications are attractive biomarkers.
  • Results suggest that urinary soluble Met may have utility as a bladder cancer marker for screening, treatment follow-up and clinical trial design.
  • The role of commensal gut microbiota in both the innate and adaptive immune responses to tumors as well as with the use of anticancer agents is under study.

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.
  • 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.
  • Undertake genetic analysis of both prokaryotic and eucaryotic samples for advanced mutational analysis.

Eligibility:

  • Patients whose biospecimens are of interest to NIH investigators.
  • 18 year of age or older.

Design:

Patient cases will be evaluated at NCI or Interventional Radiology, NIH Clinical Center. Blood, tissue, urine, saliva or other samples may be collected at the initial visit and at follow-up visits.

  Eligibility

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

  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 ClinicalTrials.gov identifier: NCT00034216

Contacts
Contact: Sheri A McMahon, R.N. (301) 496-9812 smcmahon@mail.nih.gov
Contact: James L Gulley, M.D. (301) 496-4916 gulleyj@mail.nih.gov

Locations
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)
Investigators
Principal Investigator: James L Gulley, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00034216     History of Changes
Other Study ID Numbers: 020179  02-C-0179 
Study First Received: April 24, 2002
Last Updated: May 11, 2016
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 28, 2016