Human Samples and Data Repository

August 25, 2022 updated by: National Eye Institute (NEI)

Laboratory of Immunology/National Eye Institute Repository

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

1862

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who were followed in terminated branch protocols under which data or samples were collected.

Description

  • Data Analysis Study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2007

Primary Completion (Actual)

May 6, 2021

Study Completion (Actual)

August 19, 2022

Study Registration Dates

First Submitted

October 3, 2007

First Submitted That Met QC Criteria

October 3, 2007

First Posted (Estimate)

October 4, 2007

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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