The Use of Digital Genetic Assistant (DGA) for Expanded Carrier Screening
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|ClinicalTrials.gov Identifier: NCT04014114|
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment|
|Genetic Disease||Other: Digital Genetic Assistant|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||The Use of Digital Genetic Assistant (DGA) for Expanded Carrier Screening|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
- Other: Digital Genetic Assistant
An end-to-end digital solution to the carrier screening process from participant registration to receipt of the test results and their interpretations. These steps are provided using personalized animated videos.
- Change in the number of post-test face-to-face/telephone genetic counseling sessions [ Time Frame: One year ]The investigators expect a significant change in the number of post-test face-to-face/telephone genetic counseling sessions. The current practice of expanded carrier screening provides a genetic counseling session to each couple who one of them is found to be a carrier of a genetic disease. Following the CarrierScan, expanded carrier screening test, ~60% of the couples are expected to be carriers of at least one disease. Using the DGA, the investigators expect that in the vast majority of the cases (>95%), when low risk is identified, the couple will be informed by the DGA without requiring a face-to-face/telephone session. The investigators expect that some of the low risk couples that received digital report will still request further counseling. The investigators estimate this fraction to be 10-20% of the low risk participants.
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): NCT04014114
|Contact: Ayala Lagziel, PhD||+972 54 444 email@example.com|
|Principal Investigator:||Elon Pras, Prof.||Sheba Medical Center|