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Rare Disease Patient Registry: Coordination of Rare Diseases at Sanford (CoRDS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Sanford Health
Sponsor:
Information provided by (Responsible Party):
Sanford Health
ClinicalTrials.gov Identifier:
NCT01793168
First received: February 13, 2013
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

The purpose of this registry is to create a central resource that connects scientists conducting rare disease research studies with affected individuals interested in participating in research.


Condition
Rare Disorders
Undiagnosed Disorders
Disorders of Unknown Prevalence

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 100 Years
Official Title: Coordination of Rare Diseases at Sanford

Resource links provided by NLM:


Further study details as provided by Sanford Health:

Primary Outcome Measures:
  • To accelerate research into rare disorders by connecting individuals who are interested in research and who have been diagnosed with a rare disorder (or a disorder of unknown prevalence, or who are undiagnosed) with researchers who study rare diseases. [ Time Frame: 100 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen collection capability anticipated in 2014.


Estimated Enrollment: 10000
Study Start Date: July 2010
Estimated Primary Completion Date: December 2100 (Final data collection date for primary outcome measure)
Detailed Description:

CoRDS collects contact, sociodemographic and health information about participants. This information is entered into CoRDS and linked to a unique coded identifier. Below are some examples of information requested on the Questionnaire that will be entered into CoRDS:

  • Contact information: Name, Mailing Address, Phone Number, Email Address
  • Sociodemographic information: Date of Birth, Place of Birth, Sex, Gender, Ethnicity
  • Health information: Family History, Information related to Diagnosis

De-identified information in CoRDS will be made available to researchers, if they have obtained approval for their research project from (1) the Institutional Review Board (IRB) at the researcher's institution and (2) a panel of experts led by Dr. David A. Pearce.

A subset of de-identified information collected from each profile may be shared with certain other databases. This is done in order to help improve understanding of rare diseases, to avoid the duplication of efforts and to collaborate with existing research efforts and organizations dedicated to rare diseases.

Participants may elect to have their information shared with patient advocacy groups (PAGs) representing individuals with rare or uncommon diseases who have partnered with CoRDS. The PAG will sign an agreement stating that they will not use the information for Research purposes. Dr. David A. Pearce and CoRDS personnel will not be held responsible for the use of information by the PAG.

The CoRDS Registry will not be paid by Researchers, Other Patient Registries or Patient Advocacy Groups (PAGs) for access to information in CoRDS.

If a parent/LAR consents on behalf of a minor, CoRDS will contact the participant when he or she reaches the age of 18 in order to obtain consent. If this consent is not obtained in a timely manner, the participant will be withdrawn from CoRDS.

CoRDS contacts participants annually to confirm continued interest in participation in CoRDS, and to request that participants update the information they have provided.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

English speakers, globally

Criteria

Inclusion Criteria:

  • Diagnosis of a rare disease, a disease of unknown prevalence, or undiagnosed
  • Must be fluent in English

Exclusion Criteria:

  • Does not speak English
  • Is a ward of the state
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793168

Contacts
Contact: Liz Donohue 1-877-658-9192 cords@sanfordhealth.org

Locations
United States, South Dakota
Sanford Health Recruiting
Sioux Falls, South Dakota, United States, 57104
Principal Investigator: David A Pearce, PhD         
Sponsors and Collaborators
Sanford Health
Investigators
Principal Investigator: David A Pearce, PhD Sanford Health
  More Information

Additional Information:
No publications provided

Responsible Party: Sanford Health
ClinicalTrials.gov Identifier: NCT01793168     History of Changes
Other Study ID Numbers: 03-10-014
Study First Received: February 13, 2013
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Sanford Health:
Rare Diseases
Neglected Diseases
Orphan Diseases
Rare Disease Research
Registries

Additional relevant MeSH terms:
Disease
Rare Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014