The Informed Genetics Annotated Patient Registry

Part of paid clinical trials in Redding, California.

Sponsor
Medneon
Study ID
NCT04419896
Status
Enrolling By Invitation

Conditions

  • Predisposition, Genetic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

This prospective and retrospective registry will evaluate the clinical effectiveness of Germline Genetic, Genomic, and other Biomarker testing results over time in different clinical populations, in order to shape guidelines for testing, patient management, and precision therapy.

Key Dates

Start date
Jan 23, 2019
Status verified
Apr 2022
Primary completion
Jan 1, 2025
Completion
Jan 1, 2030

Study Design

Enrollment
10,000 participants (estimated)

Arms

  • Arm: Retrospective
    Inclusion criteria for Retrospective Subjects: * Men and women 18 years or older; * Is or was a patient of a Participating Practice and was previously tested with Germline, Genomic, or other Biomarker Tests; and * For Germline Genetic Test patients, have a diagnosis of cancer or pathogenic or likely pathogenic (P/LP) result.
  • Arm: Prospective
    Inclusion criteria for Prospective Subjects: * Men and women aged 18 years or older; * Presents consecutively to a Participating Practice and who has previously been screened and tested (i.e., is a new patient scheduled for a visit at a Participating Practice or is an existing patient who returns to a Participating Practice); * Receives or has received Germline, Genomic, or other Biomarker Testing, either through a prior healthcare provider or a Participating Practice; and * Consents to be a part of the Registry.

Primary Outcome Measure

To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings. [ Time Frame: 10 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
North Valley Breast ClinicReddingCalifornia96001-
Advocate Good ShepherdBarringtonIllinois60010-
Comprehensive Breast CareTroyMichigan48098-
Nashville Breast CenterNashvilleTennessee37203-
Dallas SurgicalDallasTexas75230-

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