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Trial record 20 of 9018 for:    Genetic Diseases, Inborn AND genetic disorder

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
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by (Responsible Party):
Igentify Ltd

Brief Summary:
The DGA provides an end-to-end digital solution to the preconception carrier screening process from participant registration to receipt of the test results and their interpretations. These steps are provided using personalized animated videos.

Condition or disease Intervention/treatment
Genetic Disease Other: Digital Genetic Assistant

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Couples (Male + Female) that plan to have children together.
Criteria

Inclusion Criteria:

  • Participants willing to undergo expanded preconception carrier screening (CarrierScan Screening Test).
  • Participants willing to use the DGA as part of their genetic screening.
  • Participants willing to fill up questionnaires about their experience and understanding of the genetic counseling and share their clinical and DGA usage data with the study personnel.
  • Fluent in Hebrew.
  • Couples (Male + Female) that plan to have children together.
  • Age above 18.

Exclusion Criteria:

  • Individuals that undergo bone marrow transplantation.
  • Participants refusing to participate 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): NCT04014114


Contacts
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Contact: Ayala Lagziel, PhD +972 54 444 3074 ayala.lagziel@igentify.com

Sponsors and Collaborators
Igentify Ltd
Sheba Medical Center
Investigators
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Principal Investigator: Elon Pras, Prof. Sheba Medical Center

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Responsible Party: Igentify Ltd
ClinicalTrials.gov Identifier: NCT04014114     History of Changes
Other Study ID Numbers: 007241
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Genetic Diseases, Inborn