Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031408
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2002-03-05
Brief Title:
Consent for Use of Stored Patient Specimens for Future Testing
Sponsor:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Organization:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Study Overview
Official Title:
Plan for Obtaining Informed Consent to Use Stored Human Biological Materials HBM for Currently Unspecified Analyses
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The purpose of this study is to obtain informed consent to use stored human biological materials HBM eg blood and other tissues for future studies that may include genetic testing
Detailed Description:
During past present and future Adult AIDS Clinical Trials Group AACTG clinical trials samples of HBM eg blood other body fluids and tissues have been or will be obtained and stored until analyzed as defined by the particular trial for which the patient provided consent Some HBM may be left over after a trial is completed Important questions may arise during the design of a study some of these questions may be addressed only with archived rather than prospectively collected HBMs To improve understanding of HIV disease and its optimal management it is critical that HBMs be available to investigators for subsequent unspecified analyses
All patients are asked to sign the informed consent form and specify whether or not they agree to allow their leftover samples to be used for secondary analyses and whether or not they agree to have one 14 ml blood sample drawn in this study for DNA archiving for use in currently unspecified genetic analyses Only under extraordinary circumstances will any individual patient from whom HBM was obtained be notified of any test result from secondary testing Patients who do not agree to either option will indicate this on the informed consent and will have no further involvement in this study Declining consent does not in any way jeopardize participation in any other current or future ACTG clinical trial Consent may be obtained at the same time the patient is being enrolled into any ACTG clinical trial at some interval after the patient has entered but is still participating in a trial or at any time after the patient has completed participation in a trial The goal of this study is to allow archived HBM to be used for research purposes while protecting the identity of patients from whom such samples were obtained The focus is on obtaining permission to analyze archived HBM in ways not planned at the time the initial informed consent was obtained
All patients are asked to sign the informed consent form and specify whether or not they agree to allow their leftover samples to be used for secondary analyses and whether or not they agree to have one 14 ml blood sample drawn in this study for DNA archiving for use in currently unspecified genetic analyses Only under extraordinary circumstances will any individual patient from whom HBM was obtained be notified of any test result from secondary testing Patients who do not agree to either option will indicate this on the informed consent and will have no further involvement in this study Declining consent does not in any way jeopardize participation in any other current or future ACTG clinical trial Consent may be obtained at the same time the patient is being enrolled into any ACTG clinical trial at some interval after the patient has entered but is still participating in a trial or at any time after the patient has completed participation in a trial The goal of this study is to allow archived HBM to be used for research purposes while protecting the identity of patients from whom such samples were obtained The focus is on obtaining permission to analyze archived HBM in ways not planned at the time the initial informed consent was obtained
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 1U01AI068636 | NIH | None | httpsreporternihgovquickSearch1U01AI068636 |