Clinical trial NCT04419896: The Informed Genetics Annotated Patient Registry
Official title: The Informed Genetics Annotated Patient Registry: The iGAP Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Predisposition, Genetic
Lead sponsor: Medneon
Sponsor class: INDUSTRY
First posted: 2020-06-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals 18 years or older who meet eligibility criteria, who is screened and tested for or receives or has received Germline, Genomic, or other Biomarker Testing.

Brief summary: 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.

Detailed description: Interest and knowledge about the genetics and biology of an individual's inherited risk of disease and progression of disease is growing. Physicians are increasing using tests and technology, including Germline Genetic, Genomic, and Biomarker Testing, to provide insight into a healthy individual's risk and an affected individual's disease characteristics, in order to provide individualized clinical treatments. However, many barriers to widespread and appropriate Germline Genetic, Genomic, and Biomarker Testing persist due to complex guidelines for use, varied quality and cost, rapid advances, and adequate understanding of appropriate implementation by medical professionals. The iGAP Registry is a multi-center ongoing database designed to capture information on disease risk assessment, Germline Genetic, Genomic, and Biomarker Testing, and their utilization and impact on treatment practices and outcomes to help determine, over time, the most effective use of testing in varied patient populations and to support the increased use of precision medicine.

Eligibility criteria: 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.

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 outcomes:
measure: To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings.
timeFrame: 10 years
Secondary outcomes:
measure: To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing.
timeFrame: 10 years
Other outcomes:
Locations:
city: Redding
country: United States
facility: North Valley Breast Clinic
state: California
city: Barrington
country: United States
facility: Advocate Good Shepherd
state: Illinois
city: Troy
country: United States
facility: Comprehensive Breast Care
state: Michigan
city: Nashville
country: United States
facility: Nashville Breast Center
state: Tennessee
city: Dallas
country: United States
facility: Dallas Surgical
state: Texas
Study officials:
References: