Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT00034216 |
Other study ID # |
020179 |
Secondary ID |
02-C-0179 |
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 16, 2002 |
Study information
Verified date |
June 3, 2024 |
Source |
National Institutes of Health Clinical Center (CC) |
Contact |
Sheri A McMahon, R.N. |
Phone |
(240) 760-7968 |
Email |
sheri.mcmahon[@]nih.gov |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
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:
- 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.