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TerminatedNCT00539370Updated Aug 26, 2022

Human Samples and Data Repository

An observational study in Uveitis and Scleritis, sponsored by National Eye Institute (NEI). Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-08-26.

Sponsored by National Eye Institute (NEI) · Observational

Why this study was terminated
The investigator is no longer employed at NIH.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,862
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Uveitis
  • Scleritis

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Keywords

  • Scleritis
  • Intermediate Uveitis
  • Posterior Uveitis
  • Intraocular Inflammatory Disease
  • Data Analysis
  • Data Collection
  • Sample Analysis
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

  • Data Analysis Study
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,862 participants (actual)
Biospecimen retention
Samples with dna
05

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
06

References and documents

07

Registry details

Key details

Study ID
NCT00539370
Lead sponsor
National Eye Institute (NEI)
Responsible party
Sponsor
First posted
Oct 4, 2007
Start date
Aug 29, 2007
Primary completion
May 6, 2021
Completion
Aug 19, 2022
Last update
Aug 26, 2022

Study contacts

Hatice N Sen, M.D.
principal investigator · National Eye Institute (NEI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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