The Informed Genetics Annotated Patient Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Informed Genetics Annotated Patient Registry: The iGAP Registry

Conditions
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Predisposition, Genetic

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective<br>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. | |
| Prospective<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings. | To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings. The registry will gather information on patient demographics and personal and family history, as well as test results of Germline Genetic, Genomic, and Biomarker tests. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing. | To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing. This registry will gather information to capture the clinical management decision making processes of the physicians, before and after receiving information from Germline Genetic, Genomic, or other Biomarker testing. Further, this registry will collect information on Patient Reported Outcomes, or patient described impacts of Germline Genetic, Genomic, or other Biomarker testing on their treatment, clinician interactions, follow-up, and mental health. | 10 years |