NCT04038905

Brief Summary

The DGC provides an end-to-end solution to the Oncogenetics screening process from participant registration to receipt of the genetic test results and their interpretation. These steps are provided using personalized animated videos.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

January 30, 2020

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

July 28, 2019

Last Update Submit

January 29, 2020

Conditions

BRCA Mutations

Outcome Measures

Primary Outcomes (1)

  • Change in number of face-to-face pre-test and post-test genetic counseling sessions

    The investigators expect that the pre-test session of all participants will be handled using the enrollment module of the system making the face-to-face session unneeded. In addition, the investigators expect that about 10% of BRCA negative, low risk women that received digital counseling will still request a face-to-face counseling session. Overall, the investigators estimate that the 55% of the women will not require a post-test face-to-face session.

    One year

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Israeli female

You may qualify if:

  • Participants willing to undergo BRCA1/2 genotyping
  • Participants willing to use the DGC as part of their genetic screen
  • Participants willing to fill up follow up questionnaires about their experience and understanding of the genetic counseling, and share their clinical and DGC usage data with the study personnel
  • Fluent in Hebrew
  • Age 18 or above

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Elon Pras, Prof.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayala Lagziel, PhD

CONTACT

+972 54 444 3074ayala.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

July 28, 2019

First Posted

July 31, 2019

Study Start

April 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2022

Last Updated

January 30, 2020

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share