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: RetrospectiveInclusion 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: ProspectiveInclusion 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| North Valley Breast Clinic | Redding | California | 96001 | - |
| Advocate Good Shepherd | Barrington | Illinois | 60010 | - |
| Comprehensive Breast Care | Troy | Michigan | 48098 | - |
| Nashville Breast Center | Nashville | Tennessee | 37203 | - |
| Dallas Surgical | Dallas | Texas | 75230 | - |
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