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Sudden Unexplained Death in Childhood (SUDC) Registry (SUDC)

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: NCT03109197
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : May 10, 2019
Sponsor:
Collaborators:
Columbia University
Mayo Clinic
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The purpose is to increase the understanding of the characteristics, circumstances, medical histories and pathologies of children from ages 11 months through 18 years who have died suddenly and unexpectedly, and in some instances, without explanation. The SUDC Registry and Research Collaborative will analyze cases of sudden unexpected deaths in these children to understand risk factors and causes, and develop preventative measures.

Condition or disease Intervention/treatment
Sudden Unexplained Death Syndrome Sudden Unexplained Death in Childhood Other: Biospecimin Collection

Detailed Description:
  • 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1300 participants
Observational Model: Family-Based
Time Perspective: Prospective
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 1, 2019
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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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
Study Population
1300 participants (400 SUDC subjects and 800 parents, and approximately 100 siblings or symptomatic second degree relatives) over a period of 5 years, including both retrospectively and prospectively ascertained cases.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

SUDC Subjects

  • 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.


Information from the National Library of Medicine

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


Contacts
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Contact: Anjanette Burns ajanette.burns@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Laura Crandall       laura.crandall@nyumc.org   
Principal Investigator: Orin Devinsky, MD         
Sponsors and Collaborators
NYU Langone Health
Columbia University
Mayo Clinic
Investigators
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Principal Investigator: Orrin Devinsky, MD NYU Langone Health

Additional Information:

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03109197    
Other Study ID Numbers: 14-01061
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brugada Syndrome
Death
Death, Sudden
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Genetic Diseases, Inborn