RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2015-09-16
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02450851

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * One or more objective findings pertinent to the phenotype for which a case was submitted.
  2. * No diagnosis despite evaluation by specialists who assessed the patient for the objective finding(s).
  3. * Agreement for the storage and sharing of information and biomaterials, in an identified fashion amongst the UDN centers, and in a de-identified fashion to research sites beyond the network.
  1. * Reported symptoms with no relevant objective findings.
  2. * A diagnosis explaining objective findings.
  3. * A diagnosis suggested on record review.
  4. * Unwillingness to share data.

Contacts and Locations

Study Contact

Paul Mazur
CONTACT
(844) 746-4836
udn@hms.harvard.edu

Principal Investigator

William A Gahl, M.D.
PRINCIPAL_INVESTIGATOR
National Human Genome Research Institute (NHGRI)

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
HudsonAlpha Institute for Biotechnology, Inc.
Huntsville, Alabama, 35806
United States
University of California, Los Angeles
Los Angeles, California, 90095
United States
University of California, Irvine Medical Center
Orange, California, 92668
United States
Lucile Salter Packard Children's Hospital at Stanford
Stanford, California, 94020
United States
Stanford University
Stanford, California, 94305-5584
United States
Leland Stanford Junior University
Stanford, California, 94305
United States
Stanford Hospital and Clinics
Stanford, California, 94305
United States
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
United States
University of Miami Miller School of Medicine
Miami, Florida, 33136
United States
Lurie Children s Hospital
Chicago, Illinois, 60611
United States
Indiana University
Indianapolis, Indiana, 46202-5262
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Boston Children s Hospital
Boston, Massachusetts, 02115
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Harvard T.H. Chan School of Public Health
Boston, Massachusetts, 02115
United States
Harvard U Faculty of Medicine
Boston, Massachusetts, 02115
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University in St. Louis
St Louis, Missouri, 63110
United States
New York Genome Center
New York, New York, 10013
United States
Duke University Health System
Durham, North Carolina, 27710
United States
University of Oregon
Eugene, Oregon, 97403
United States
Oregon Health Sciences University
Portland, Oregon, 97201-3098
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6056
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84112
United States
Pacific Northwest National Laboratory
Richland, Washington, 99354
United States
Seattle Children's Hospital
Seattle, Washington, 98101
United States
University of Washington
Seattle, Washington, 98195
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: National Human Genome Research Institute (NHGRI)

  • William A Gahl, M.D., PRINCIPAL_INVESTIGATOR, National Human Genome Research Institute (NHGRI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-09-16
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2015-09-16
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Rare Diseases
  • Undiagnosed Diseases
  • Natural History

Additional Relevant MeSH Terms

  • Genetic Disease