Consent for Use of Stored Patient Specimens for Future Testing

Sponsor

AIDS Clinical Trials Group (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00031408

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

30,000

Enrollment

Locations

262.5

Anticipated Duration (Months)

476.2

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to obtain informed consent to use stored human biological materials (HBM) (e.g., blood and other tissues) for future studies that may include genetic testing.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections

Detailed Description

During past, present, and future Adult AIDS Clinical Trials Group (AACTG) clinical trials, samples of HBM (e.g., 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Plan for Obtaining Informed Consent to Use Stored Human Biological Materials (HBM) for Currently Unspecified Analyses

Actual Study Start Date :

Feb 13, 2002

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Parent or guardian willing to give informed consent, if applicable
Either currently participating in or have ever participated in an AACTG clinical trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California	United States	900331079
2	Charles Drew Medical Center	Los Angeles	California	United States	90059
3	UCLA CARE Ctr	Los Angeles	California	United States	90095
4	Univ of California, San Diego	San Diego	California	United States	92103
5	Univ of California San Francisco	San Francisco	California	United States	94110
6	San Mateo AIDS Program / Stanford Univ	Stanford	California	United States	943055107
7	Stanford Univ Med Ctr	Stanford	California	United States	943055107
8	Willow Clinic / Stanford Univ	Stanford	California	United States	94305
9	Harbor General/UCLA	Torrance	California	United States	90502
10	Univ of Colorado Health Sciences Ctr	Denver	Colorado	United States	80262
11	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
12	Univ of Miami School of Medicine	Miami	Florida	United States	331361013
13	Emory Univ	Atlanta	Georgia	United States	30308
14	Northwestern Univ Med School	Chicago	Illinois	United States	60611
15	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
16	The CORE Ctr	Chicago	Illinois	United States	60612
17	Indiana Univ Hosp	Indianapolis	Indiana	United States	46202-5250
18	Methodist Hosp of Indiana / Life Care Clinic	Indianapolis	Indiana	United States	46202
19	Wishard Hosp	Indianapolis	Indiana	United States	46202
20	Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS (1504)	Iowa City	Iowa	United States	52242
21	Univ of Maryland, Institute of Human Virology	Baltimore	Maryland	United States	21201
22	Johns Hopkins Hosp	Baltimore	Maryland	United States	21287
23	Harvard (Massachusetts Gen Hosp)	Boston	Massachusetts	United States	02114
24	Boston Med Ctr	Boston	Massachusetts	United States	02118
25	Beth Israel Deaconess - West Campus	Boston	Massachusetts	United States	02215
26	Brigham and Women's Hosp	Boston	Massachusetts	United States	02215
27	Univ of Minnesota	Minneapolis	Minnesota	United States	55455
28	Washington Univ / St Louis Connect Care	Saint Louis	Missouri	United States	63108
29	Washington Univ School of Medicine	Saint Louis	Missouri	United States	63108
30	Specialty Care Center CRS 1505	Omaha	Nebraska	United States	681985130
31	New Jersey Medical School- Adult CRS (31477)	Newark	New Jersey	United States	07103
32	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York	United States	14215
33	Beth Israel Med Ctr	New York	New York	United States	10003
34	Cornell Clinical Trials Unit - Chelsea Clinic	New York	New York	United States	10011
35	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
36	Cornell Univ Med Ctr	New York	New York	United States	10021
37	The Cornell Clinical Trials Unit	New York	New York	United States	10021
38	Mount Sinai Med Ctr	New York	New York	United States	10029
39	Columbia Presbyterian Med Ctr	New York	New York	United States	10032
40	Community Health Network Inc	Rochester	New York	United States	14642
41	St Mary's Hosp (Univ of Rochester/Infectious Diseases)	Rochester	New York	United States	14642
42	Univ of Rochester Medical Center	Rochester	New York	United States	14642
43	Wake County Health and Human Services CRS (30076)	Chapel Hill	North Carolina	United States	27514
44	Univ of North Carolina	Chapel Hill	North Carolina	United States	275997215
45	Duke Univ Med Ctr	Durham	North Carolina	United States	27710
46	Greensboro CRS	Greensboro	North Carolina	United States	27401
47	Univ of Cincinnati	Cincinnati	Ohio	United States	452670405
48	Cleveland Clinic (A2508)	Cleveland	Ohio	United States	44106-5083
49	Case Western Reserve Univ	Cleveland	Ohio	United States	44106
50	Ohio State Univ Hosp Clinic	Columbus	Ohio	United States	43210-1228
51	The Research & Education Group-Portland CRS (31474)	Portland	Oregon	United States	97210
52	Penn Therapeutics CRS (6201)	Philadelphia	Pennsylvania	United States	19104
53	Presbyterian Med Ctr	Philadelphia	Pennsylvania	United States	19104
54	Univ of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
55	University of Pennsylvania, ACTU	Philadelphia	Pennsylvania	United States	19104
56	Univ of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
57	Miriam Hosp / Brown Univ	Providence	Rhode Island	United States	02906
58	Vanderbilt Univ Med Ctr	Nashville	Tennessee	United States	37203
59	Dallas VA Medical Center (3752)	Dallas	Texas	United States	75235-9173
60	Univ of Texas, Southwestern Med Ctr of Dallas	Dallas	Texas	United States	75390
61	Virginia Commonwealth Univ. Medical Ctr. CRS (31475)	Richmond	Virginia	United States	23219
62	Univ of Washington	Seattle	Washington	United States	98104
63	Univ of Puerto Rico	San Juan		Puerto Rico	365067