UveitisNCT00539370
Human Samples and Data Repository
An observational study of Uveitis and Scleritis, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- How many people
- 1,862 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2007to 19 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who were followed in terminated branch protocols under which data or samples were collected.
- Data Analysis Study
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
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.
- Keywords
- Scleritis, Intermediate Uveitis, Posterior Uveitis, Intraocular Inflammatory Disease, Data Analysis, Data Collection, Sample Analysis
- Medical subject headings
- Uveitis, Scleritis, Uveitis, Intermediate, Uveitis, Posterior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2007 (estimated)
- Study start29 Aug 2007
- Primary completion6 May 2021
- Study completion19 Aug 2022
Why it stopped: The investigator is no longer employed at NIH.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,862 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hatice N Sen, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539370
- Sponsor's protocol ID
- 070213
- Other IDs
- 07-EI-0213
- Status last verified
- Aug 2022
- First submitted
- 3 Oct 2007
- Last updated
- 26 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory of Immunology/National Eye Institute Repository
- ClinicalTrials.gov ID
- NCT00539370
- Acronym / sponsor ID
- 070213
- Keywords
- Scleritis, Intermediate Uveitis, Posterior Uveitis, Intraocular Inflammatory Disease, Data Analysis, Data Collection, Sample Analysis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The investigator is no longer employed at NIH.
- Enrolment
- 1,862 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 29 Aug 2007 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 4 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who were followed in terminated branch protocols under which data or samples were collected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: The investigator is no longer employed at NIH.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice N Sen, M.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis and Scleritis, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The investigator is no longer employed at NIH.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.