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Clinical and Genetic Evaluation of Individuals With Undiagnosed Disorders Through the Undiagnosed Diseases Network

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 70 years 8 months later Dec 31, 2028 → Sep 16, 2099
See other at-risk trials from National Human Genome Research Institute (NHGRI)

Record History

The 50 most recent of 334 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Site details revised at 4 of 33 sites
  4. Primary completion pushed from Dec 31, 2028 to Sep 16, 2099 Completion pushed from Dec 31, 2028 to Dec 31, 2099v331 Show 1 more changeShow less
    • Completion pushed from Dec 31, 2028 to Dec 31, 2099
  5. 4 versions Re-verified since Jul 16, 2026, no change to tracked fieldsv327-v330
Show 42 earlier versionsHide 42 earlier versions
  1. Site contacts updated at 1 of 33 sitesv326
  2. 6 versions Re-verified since Dec 18, 2025, no change to tracked fieldsv320-v325
  3. Site contacts updated at 1 of 33 sitesv319
  4. 13 versions Re-verified since Jul 31, 2025, no change to tracked fieldsv306-v318
  5. Site details revised at 6 of 33 sitesv305
  6. 2 versions Re-verified since Jun 17, 2025, no change to tracked fieldsv303-v304
  7. Study sites revised (33)v302 See this version in full on ClinicalTrials.gov ↗
  8. 16 versions Re-verified since Mar 19, 2025, no change to tracked fieldsv286-v301
  9. Study sites: 32 to 33v285
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Without an explanation for severe and sometimes life-threatening symptoms, patients and their families are left in a state of unknown. Many individuals find themselves being passed from physician to physician, undergoing countless and often repetitive tests in the hopes of finding answers and insight about what the future may hold. This long and arduous journey to find a diagnosis does not end for many patients- the Office of Rare Diseases Research (ORDR) notes that 6% of individuals seeking their assistance have an undiagnosed disorder. In 2008, the National Institutes of Health (NIH) Undiagnosed Diseases Program (UDP) was established with the goal of providing care and answers for these individuals with mysterious conditions who have long eluded diagnosis. The NIH UDP is a joint venture of the NIH ORDR, the National Human Genome Research Institute Intramural Research Program (NHGRI-IRP), and the NIH Clinical Research Center (CRC) (1-3). The goals of the NIH UDP are to: (1) provide answers for patients with undiagnosed diseases; (2) generate new knowledge about disease mechanisms; (3) assess the application of new approaches to phenotyping and the use of genomic technologies; and (4) identify potential therapeutic targets, if possible. To date, the UDP has evaluated 3300 medical records and admitted 750 individuals with rare and undiagnosed conditions to the NIH Clinical Center. The NIH UDP has identified more than 70 rare disease diagnoses and several new conditions. The success of the NIH UDP prompted the NIH Common Fund to support the establishment of a network of medical research centers, the Undiagnosed Diseases Network (UDN), for fiscal years 2013-2020. The clinical sites will perform extensive phenotyping, genetic analyses, and functional studies of potential disease-causing variants. The testing performed on patients involves medically indicated studies intended to help reach a diagnosis, as well as research investigations that include a skin biopsy, blood draws, and DNA analysis. In addition, the UDN will further the goals of the UDP by permitting the sharing of personally identifiable phenotypic and genotypic information within the network. By sharing participant information and encouraging collaboration, the UDN hopes to improve the understanding of rare conditions and advance the diagnostic process and care for individuals with undiagnosed diseases....
Trial Details
NCT Number NCT02450851
Lead Sponsor National Human Genome Research Institute (NHGRI)
Conditions Genetic Disease
Enrollment 20,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov