Digital Genetic Assistant (DGA) for Expanded Carrier Screening

NCT04248504 | Unknown

• 1 other identifier: MOH_2020-01-16_008638
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Genetic Disease

Outcome Measures

Primary Outcomes (1)

• The number of post-test face-to-face/telephone genetic counseling sessions

  The investigators expect a significant reduction 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 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.

  One year

Interventions

Digital Genetic Assistant OTHER

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Couples (Male + Female) that plan to have children together.

You may qualify if:

• 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 or English.
• Couples (Male + Female) that plan to have children together.
• Age above 18.

You may not qualify if:

• Individuals that undergo bone marrow transplantation.
• Participants refusing to participate in the study.

Sponsors & Collaborators

• Igentify Ltd: lead
• Tel-Aviv Sourasky Medical Center: collaborator

MeSH Terms

Conditions

Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hagit Baris-Feldman, MD

  Tel Avib Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayala Lagziel, PhD

CONTACT

+972 54 444 3074; ayala.lagziel@igentify.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 30, 2020
• Study Start: February 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2022
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share