Sudden Unexplained Death in Childhood (SUDC) Registry (SUDC)
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|ClinicalTrials.gov Identifier: NCT03109197|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : February 13, 2023
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|Condition or disease||Intervention/treatment|
|Sudden Unexplained Death Syndrome Sudden Unexplained Death in Childhood||Other: Biospecimin Collection|
- Review the child's death, medical and family history by our study pathologists (including forensic, pediatric, cardiac and neuropathologists) to determine whether a possible, probable or definite cause of death can be identified and whether additional studies might be helpful in determining a specific cause of death.
- For case investigations that are open/active, the registry offers cardiac pathology, and neuroimaging/neuropathology consultations.
- For those cases determined to be unexplained/undetermined- access to genetic analysis (whole exome sequencing) when viable samples are available. Additional genetic analysis opportunities for biological parents and some family members. For more information, please see our Genetics Frequently Asked Questions.
- Study the risks that lead to sudden unexplained death in childhood (SUDC).
- Provide families with a review of their child's death through a case review report.
- Identify at-risk individuals with the hopes of gaining knowledge to establish prevention strategies to reduce the chances of sudden unexplained death in the future.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1300 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||The SUDC Registry and Research Collaborative|
|Actual Study Start Date :||October 1, 2014|
|Estimated Primary Completion Date :||September 30, 2024|
|Estimated Study Completion Date :||September 30, 2024|
Retrospective SUDC cases
All child biospecimens (including mucosal swab or blood samples for DNA analysis, pathology slides, tissue blocks, tissue samples or organs retained at autopsy) will be transferred to NYU Biorepository
Other: Biospecimin Collection
Prospective SUDC cases
Heart and brain tissue will undergo full cardiac pathology consultation or neuropathology consultation will be transferred to pathologists at NYU or Mayo (based on pathologist availability). The PHI will remain intact in these cases since they will need to know how to identify the deceased with the medical records they receive and to complete the entire investigation thoroughly. A full consultation report will be sent back to Dr. Orrin Devinsky and tissue will be returned to the NYU biorepository upon completion of the cardiac or neuropathology consultation.
Other: Biospecimin Collection
- Risks factors leading to sudden unexplained death in childhood (SUDC) collected from PHI [ Time Frame: 5 Years ]
Biospecimen Retention: Samples With DNA
For retrospective SUDC cases: Mucosal swab or blood samples for DNA analysis, pathology slides, tissue blocks, tissue samples or organs retained at autopsy.
For prospective SUDC cases: Mucosal swab or blood samples for DNA analysis, pathology slides, tissue blocks, tissue samples except heart and brain tissue that will undergo full cardiac pathology consultation or neuropathology consultation will be transferred to pathologists at NYU or Mayo (based on pathologist availability).
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, Learn About Clinical Studies.
|Ages Eligible for Study:||11 Months to 100 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
Retrospective SUDC Cases
- 11months to 18 years of age.
- Subjects whose cause of death was sudden and unexplained-"Postinfancy SIDS," "Sudden Death of Childhood," "Undetermined," "Late SIDS," a vague description of symptoms of "undetermined etiology," or a diagnosis acknowledged to be speculative by the prosecting pathologist
- If the retrospective case has banked DNA specimens.
Prospective SUDC Cases
- SUDC cases, parents and eligible family members from 11months-100 years of age.
- SUDC Subjects whose death was sudden and unexplained after the initial autopsy, and in whom a scene investigation and full autopsy was performed.
Family Members Subjects
- If the SUDC case has DNA viable specimens, family members will be asked if they would also like to participate in the DNA portion. One or both biological parents if willing and able will be considered as a family subject.
- Biological siblings and second degree relatives from age of 0-100 years of age that have had a history or currently have a heart condition and/or neurology condition.
- Subjects that are younger than 11months or older than 18 years of age will be excluded as a SUDC case.
- Prospective SUDC cases of apparent suicide, homicide, and accident where the external cause was the obvious and only reason for the death will be excluded from this study.
Family Member Subjects Any siblings or second degree family relatives that did not have a history or current heart or neurology condition will not be able to enroll in the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109197
|Contact: Laura Gouldfirstname.lastname@example.org|
|United States, New York|
|New York University School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: Laura Crandall email@example.com|
|Principal Investigator: Orin Devinsky, MD|
|Principal Investigator:||Orrin Devinsky, MD||NYU Langone Health|
|Responsible Party:||NYU Langone Health|
|Other Study ID Numbers:||
|First Posted:||April 12, 2017 Key Record Dates|
|Last Update Posted:||February 13, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Cardiac Conduction System Disease
Genetic Diseases, Inborn