Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034216
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2002-04-24
Brief Title:
Collection of Blood From Patients With Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Biospecimen Acquisition From Human Subjects
Status:
RECRUITING
Status Verified Date:
2024-09-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-C-0179 | None | None | None |