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NCT00001373 · ClinicalTrials.gov registry record
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
A clinical trial of Fever and Genetic Diseases, sponsored by National Human Genome Research Institute (NHGRI).
- Recruiting
- Registry status
- 5,000
- Enrollment target
- 5
- Study locations
NCT00001373: Recruiting study of Fever and Genetic Diseases, sponsored by National Human Genome Research Institute (NHGRI).
NCT00001373 is a study of Fever and Genetic Diseases that is actively recruiting participants, run by National Human Genome Research Institute (NHGRI). The registered enrollment target is 5,000 participants, above the 322-participant average among 18 other Fever trials with a reported enrollment target (1453% higher). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001373, a study of Fever and Genetic Diseases, is actively recruiting participants, sponsored by National Human Genome Research Institute (NHGRI).
- RECRUITING
- Registry status
- 5,000 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older. Patients will undergo a medical and family history, physical examination, blood and urine tests. Additional tests and procedures may include the following: 1. X-rays 2. Consultations with specialists 3. DNA sample collection (blood or saliva sample) for genetic studies. These might include studies of specific genes, or more complete sequencing of the genome. 4. Additional blood samples a maximum of 1 pint (450 ml) during a 6-week period for studies of white cell adhesion (stickiness) 5. Leukapheresis for collecting larger amounts of white cells for study. For this procedure, whole blood is collected through a needle in an arm vein. The blood flows through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body through another needle in the other arm. Patients may be followed approximately every 6 months to monitor symptoms, adjust medicine dosages, and undergo routine blood and urine tests. They will receive genetic counseling by the study team on the risk of having affected children and be advised of treatment options. Participating relatives will undergo a medical and family history, possibly with a review of medical records, physical examination, blood and urine tests. Additional procedures may include a 24-hour urine collection, X-rays, and consultations with medical specialists. A DNA sample (blood or saliva) will also be collected for genetic studies. Additional blood samples of no more than 550 mL during an 8-week
Primary Outcome
discovery of genetic associations to autoinflammatory disorders
Conditions Studied
Study Locations (5)
Maryland
- Johns Hopkins University - Baltimore
- Walter Reed National Medical Center - Bethesda
- National Institutes of Health Clinical Center - Bethesda
District of Columbia
- Childrens National Medical Center - Washington D.C.
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,000 participants |
| Start Date | 1994-03-10 |
What NCT00001373 shows while recruiting
NCT00001373 is an observational study that tracks outcomes without assigning an intervention. Its 5,000 participants enrollment target places it among the larger protocols in the corpus, above the 322-participant average among 18 other Fever trials with a reported enrollment target (1453% higher).
The record links to 7 conditions, with Fever appearing as the primary indexed condition, and to 0 interventions.
NCT00001373 lists 5 locations in 3 states (Maryland, District of Columbia, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT00001373 about?
NCT00001373 is a clinical study titled "Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics". This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with know...
What is the current status of trial NCT00001373?
This trial is currently recruiting. The enrollment target is 5,000 participants. The study started on 1994-03-10.
What conditions does trial NCT00001373 study?
This clinical trial studies the following conditions: Fever, Genetic Diseases, ROSAH, Autoinflammation, Familial Mediterranean Fever (FMF).
Who is sponsoring clinical trial NCT00001373?
This trial is sponsored by National Human Genome Research Institute (NHGRI), which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001373 being conducted?
This trial has 5 study locations across District of Columbia, Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fever
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001373's enrollment target sits among peer trials
5,000 1st of 18 higher than 18 of 18 other Fever trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fever trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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