Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford (CoRDS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01793168 |
Recruitment Status :
Recruiting
First Posted : February 15, 2013
Last Update Posted : December 10, 2020
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Tracking Information | |||||
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First Submitted Date | February 13, 2013 | ||||
First Posted Date | February 15, 2013 | ||||
Last Update Posted Date | December 10, 2020 | ||||
Actual Study Start Date | July 2010 | ||||
Estimated Primary Completion Date | December 2100 (Final data collection date for primary outcome measure) | ||||
Current 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 ] | ||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford | ||||
Official Title | Coordination of Rare Diseases at Sanford | ||||
Brief Summary | CoRDS, or the Coordination of Rare Diseases at Sanford, is based at Sanford Research in Sioux Falls, South Dakota. It provides researchers with a centralized, international patient registry for all rare diseases. This program allows patients and researchers to connect as easily as possible to help advance treatments and cures for rare diseases. The CoRDS team works with patient advocacy groups, individuals and researchers to help in the advancement of research in over 7,000 rare diseases. The registry is free for patients to enroll and researchers to access. Visit sanfordresearch.org/CoRDS to enroll. | ||||
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:
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. 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 with 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. 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. |
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Study Type | Observational [Patient Registry] | ||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | 100 Years | ||||
Biospecimen | Retention: None Retained Description: Biospecimen collection capability anticipated in 2014.
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Sampling Method | Non-Probability Sample | ||||
Study Population | Unaffected carriers, undiagnosed and those with a rare disease or rare condition. | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
20000 | ||||
Original Estimated Enrollment |
1000 | ||||
Estimated Study Completion Date | December 2100 | ||||
Estimated Primary Completion Date | December 2100 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Australia, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT01793168 | ||||
Other Study ID Numbers | 03-10-014 Hypersomnia Foundation ( Registry Identifier: Hypersomnia Registry ) National Ataxia Foundation ( Registry Identifier: Ataxia Registry ) 4p- Support Group ( Registry Identifier: 4p-/Wolfhirschhorn Syndrome Registry ) CdLS Foundation ( Registry Identifier: Cornelia de Lange Syndrome Registry ) Hyperacusis Research Limited ( Registry Identifier: Hyperacusis Registry ) Kabuki Syndrome Network ( Registry Identifier: Kabuki Syndrome Registry ) Kawasaki Disease Foundation ( Registry Identifier: Kawasaki Disease Registry ) Klippel-Feil Syndrome Freedom ( Registry Identifier: Klippel-Feil Syndrome Registry ) Leiomyosarcoma Direct Research ( Registry Identifier: Leiomyosarcoma Registry ) MSS Support Group ( Registry Identifier: Marinesco-Sjogren Syndrome Registry ) ML4 Foundation ( Registry Identifier: Mucolipidosis Type IV (ML4) Registry ) Stickler Involved People ( Registry Identifier: Stickler Syndrome Registry ) IWSA ( Registry Identifier: WAGR Syndrome Registry ) Soft Bones ( Registry Identifier: Hypophosphatasia Registry ) PWN4PWN ( Registry Identifier: Narcolepsy Registry ) aHUS ( Registry Identifier: aHUS Registry ) Klippel-Feil Syndrome Alliance ( Registry Identifier: KFS Registry ) American MEN Support ( Registry Identifier: Mulitiple Endocrine Neoplasia Registry ) Kleine-Levin Syndrome ( Registry Identifier: Kleine-Levin Syndrome Registry ) All Things Kabuki ( Registry Identifier: Kabuki Syndrome Registry ) WSS Foundation ( Registry Identifier: Wiedemann-Steiner Syndrome Registry ) BIVA ( Registry Identifier: Brest Implant-Associated ALCL Registry ) ABDA ( Registry Identifier: American Bechet's Disease Association Registry ) PROS Foundation (HLH) ( Registry Identifier: Hemophagocytic Lymphohistiocytosis (HLH) Registry ) Alagille Syndrome Association ( Registry Identifier: Alagillle Syndrome Registry ) Cure VCP Disease, Inc. ( Registry Identifier: IBMPFD Registry ) Lowe Syndrome Association ( Registry Identifier: Lowe Syndrome Registry ) Pitt Hopkins ( Registry Identifier: Pitt Hopkins Registry ) Cure Batten Disease ( Registry Identifier: Batten Disease Registry ) Hypnic Jerk/Sleep Myoclonus ( Registry Identifier: Hypnic Jerk/Sleep Myoclonus Registry ) 1p36 DSA ( Registry Identifier: 1p36 Deletion Syndrome Registry ) Jansen Foundation ( Registry Identifier: The Jansen Foundation Registry ) Share and Care Network ( Registry Identifier: Cockayne Syndrome Registry ) CRMO ( Registry Identifier: CRMO Registry ) The Malan Syndrome Foundation ( Registry Identifier: Malan Syndrome Registry ) HSAN1E Society ( Registry Identifier: HSAN1E Registry ) Alstrom United Kingdomg ( Registry Identifier: Alstrom United Kingdom ) Athymia ( Registry Identifier: Athymia ) CRB1 Foundation ( Registry Identifier: Curing Retinal Blindness Foundation ) Cystinosis Research Foundation ( Registry Identifier: Cystinosis Research Foundation ) DNM1 Families ( Registry Identifier: DNM1 Mutations ) Global DARE Foundation ( Registry Identifier: Global DARE Foundation ) KCIAF ( Registry Identifier: KCNMA1 Channelopathy International Advocacy Foundation ) MSUD FSG ( Registry Identifier: Maple Syrup Urine Disease Family Support Group ) IamGSD ( Registry Identifier: International Association for Muscle Glycogen Storage Disease ) Myhre Syndrome Foundation ( Registry Identifier: Myhre Syndrome Foundation ) NCBRS ( Registry Identifier: Nicolaides Baraitser Syndrome Worldwide Foundation ) PBCers Organization ( Registry Identifier: PBCers Organization ) DBA - PFIC Network ( Registry Identifier: Progressive Familial Intrahepatic Cholestasis Advocacy and Resource Network, Inc ) Remember the Girls ( Registry Identifier: Remember the Girls - X-Linked Carriers ) RRPF ( Registry Identifier: Recurrent Respiratory Papillomatosis Foundation ) SKS Foundation ( Registry Identifier: Smith-Kingsmore Syndrome Foundation ) SPG15 Research Foundation ( Registry Identifier: SPG Research Foundation ) Team Telomere ( Registry Identifier: Team Telomere ) TGA Project ( Registry Identifier: Transient Global Amnesia Project ) The Cute Syndrome Foundation ( Registry Identifier: The Cute Syndrome Foundation ) WSS Foundation ( Registry Identifier: White Sutton Syndrome Foundation ) Zmynd11 Gene Disorder ( Registry Identifier: Zmynd11 Gene Disorder ) SPG11 and SPG15 ( Registry Identifier: The Maddi Foundation ) Endosalpingiosis Foundation ( Registry Identifier: Endosalpingiosis Foundation, Inc ) Cauda Equina Foundation ( Registry Identifier: Cauda Equina Foundation, Inc ) Tango2 Research Foundation ( Registry Identifier: Tango2 Research Foundation ) SMC1A Epilepsy ( Registry Identifier: SMC1A Epilepsy Foundation ) IFFGD ( Registry Identifier: International Foundation for Gastrointestinal Disorders ) Noah's Hope - Hope4Bridget ( Registry Identifier: Noah's Hope - Hope4Bridget Foundation ) Project Sebastian ( Registry Identifier: Project Sebastian ) ISACRA ( Registry Identifier: International Sacral Agenesis/Caudal Regression Association (SACRA) ) Scheuermann's Disease Fund ( Registry Identifier: Scheuermann's Disease Fund ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Sanford Health | ||||
Study Sponsor | Sanford Health | ||||
Collaborators |
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Investigators | Not Provided | ||||
PRS Account | Sanford Health | ||||
Verification Date | July 2020 |