Human Samples and Data Repository

Terminated

• Conditions: Uveitis; Scleritis

• Registration Number: NCT00539370
• Lead Sponsor: National Eye Institute (NEI)

Brief Summary

This protocol will enable IRB (institutional review board) review of proposed research using human samples and data collected under the terminated NIH studies 04-EI-0065 and 96-EI-0096. Data and samples may include demographic and personal health information, psychological or psychiatric testing, blood, urine, CSF or other body fluids or tissues and results of medical and physiological evaluation and medical imaging.

Data and sample analyses are limited to those approved under the original protocols unless additional specific institutional review board approval is obtained.

Detailed Description

Objective: This protocol will enable prospective IRB review of research using human samples and data collected under other branch protocols.

Study population: Participants that were followed in terminated branch protocols under which data or samples were collected.

Design: Samples and data will be brought under this protocol, analyzed and stored for uses specified in the original protocols and as additionally approved by the IRB.

Outcome: The outcome of this protocol will be the storage, tracking, and utilization of samples and data obtained under terminated protocols.

Purpose: The purpose of this protocol is to enable prospective IRB review of research using human samples and data collected under other branch protocols.

Participants: Participants who previously participated in NIH protocols whose wishes regarding use of their samples or data for research other than that specified in the initial protocol is not known may be enrolled in this protocol. At this time, there are no additional analyses planned outside of the original protocols, apart from those listed below. Participant consent or IRB approval for a waiver of additional informed consent will be sought prior to initiation of additional analyses.

Study Timeline

• Study Start: 2007-08-29
• Study First Submitted: 2007-10-03
• Study First Submitted QC: 2007-10-03
• Study First Posted: 2007-10-04
• Primary Completion: 2021-05-06
• Status Verified: 2022-08
• Study Completion: 2022-08-19
• Last Update Submitted: 2022-08-25
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1862

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States