Collection of Blood From Patients With Cancer
Conditions
Prostate Cancer - Breast Cancer - Colon Cancer - Lung Cancer - Liver Cancer
Conditions: Keywords
Suppressor Cells, T-cells, CD4+/CD25+ Cells, Cancer, Malignancy, Blood Sample
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Overall Status
Recruiting
Summary
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.
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, 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 procariotic and eucariotic samples for advanced mutational analysis.

Eligibility:

- Patients undergoing evaluation for participation in NCI treatment protocols in the NCI intramural program with diagnosis of cancer.

- 18 year of age or older.

Design:

Patients with a prior diagnosis of malignancy or refractory cancer 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.

Patients with malignancy are eligible.

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.
Location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Status: Recruiting
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office - (888) NCI-1937
Start Date
April 2002
Sponsors
National Cancer Institute (NCI)
Source
National Institutes of Health Clinical Center (CC)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page