Collection of Blood From Patients With Cancer
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Biospecimen Acquisition From Human Subjects|
- 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 ]
- 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 ]
|Study Start Date:||April 2002|
- 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.
- 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.
- Patients whose biospecimens are of interest to NIH investigators.
- 18 year of age or older.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034216
|Contact: Sheri A McMahon, R.N.||(301) email@example.com|
|Contact: James L Gulley, M.D.||(301) firstname.lastname@example.org|
|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|
|Principal Investigator:||James L Gulley, M.D.||National Cancer Institute (NCI)|