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NCT02156102 · ClinicalTrials.gov registry record
Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers Study (INSIGHTS Study)
A clinical trial of Genetic Disease and Genomics, sponsored by National Human Genome Research Institute (NHGRI).
- Completed
- Registry status
- 405
- Enrollment target
- 3
- Study locations
NCT02156102: Completed study of Genetic Disease and Genomics, sponsored by National Human Genome Research Institute (NHGRI).
NCT02156102 is a study of Genetic Disease and Genomics that has completed, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 405 participants, below the 2,548-participant average among 30 other Genetic Disease trials with a reported enrollment target (84% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02156102, a study of Genetic Disease and Genomics, has completed, sponsored by National Human Genome Research Institute (NHGRI).
- COMPLETED
- Registry status
- 405 participants
- Enrollment target
- 3
- Study locations
Study Summary
Background: \- People with sickle cell disease and other blood disorders sometimes get chronic leg ulcers. These are wounds that develop on the skin and don t go away. Current treatments do not work very well, so researchers want to learn more about why the ulcers happen. They want to find out which bacteria may cause it, and if external factors play a role. Objective: \- To study social and environmental factors of sickle cell disease and the causes of sickle cell disease leg ulcers. Eligibility: \- People age 18 and older who have sickle cell disease or another red cell disorder, with or without an active leg ulcer. Design: * Participants will have a medical history and clinical evaluation. They will also have blood drawn. * Participants will complete questionnaires about their life, health, environment, stress, and other topics. * Participants may provide a small sample of hair. * Participants will be asked to collect a small amount of saliva. * Participants with leg ulcers will have their skin microbiome sampled. The microbiome is all of the microbes (bacteria and and/or fungi) and their genes in and on the body. Researchers will use swabs to collect skin samples. Photographs will be taken of the skin sample area. * Some participants without leg ulcers also will have their skin microbiome sampled. * Some participants who have their skin microbiome sampled will return for a second visit. At this visit, their microbiome will be resampled. It will take place more than 30 days after the first visit.
Primary Outcome
Employ genomic approaches to characterize the skin microbiome in individuals living with SCD with and without leg ulcers
Conditions Studied
Study Locations (3)
Maryland
- National Institutes of Health Clinical Center - Bethesda
New York
- Montefiore Medical Center/Albert Einstein College of Medicine - The Bronx
Other
- University of Sierra Leone, College of Medicine and Allied Health Services - Freetown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2014-06-16 |
| Est. Completion | 2024-10-01 |
What the finished NCT02156102 record still lists
NCT02156102 is an observational study that tracks outcomes without assigning an intervention. The registered 405 participants enrollment target is mid-sized for trials with a published cap, below the 2,548-participant average among 30 other Genetic Disease trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Genetic Disease appearing as the primary indexed condition, and to 0 interventions.
NCT02156102 reports a single indexed study location in Maryland, New York, Other.
Frequently Asked Questions
What is clinical trial NCT02156102 about?
NCT02156102 is a clinical study titled "Insights Into Microbiome and Environmental Contributions to Sickle Cell Disease and Leg Ulcers Study (INSIGHTS Study)". Background: \- People with sickle cell disease and other blood disorders sometimes get chronic leg ulcers. These are wounds that develop on the skin and don t go away. Current treatments do not work very well, so researchers want to learn more about why the ulcers happen. They want to find out whic...
What is the current status of trial NCT02156102?
This trial is currently completed. The enrollment target is 405 participants. The study started on 2014-06-16. Estimated completion is 2024-10-01.
What conditions does trial NCT02156102 study?
This clinical trial studies the following conditions: Genetic Disease, Genomics.
Who is sponsoring clinical trial NCT02156102?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02156102 being conducted?
This trial has 3 study locations across Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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405 13th of 30 higher than 18 of 30 other Genetic Disease trials
participants (enrollment target), bucketed by value
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