iGAP: The Informed Genetics Annotated Patient Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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| 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. |
Outcome Measures
Primary Outcome Measures
- To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings. [10 years]
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.
Secondary Outcome Measures
- To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing. [10 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria for Retrospective Subjects:
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Men and women 18 years or older;
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Is or was a patient of a Participating Practice and was previously tested with Germline, Genomic, or other Biomarker Tests; and
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For Germline Genetic Test patients, have a diagnosis of cancer or pathogenic or likely pathogenic (P/LP) result.
Inclusion Criteria for Prospective Subjects:
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Men and women aged 18 years or older;
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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);
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Receives or has received Germline, Genomic, or other Biomarker Testing, either through a prior healthcare provider or a Participating Practice; and
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Consents to be a part of the Registry.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | North Valley Breast Clinic | Redding | California | United States | 96001 |
| 2 | Advocate Good Shepherd | Barrington | Illinois | United States | 60010 |
| 3 | Comprehensive Breast Care | Troy | Michigan | United States | 48098 |
| 4 | Nashville Breast Center | Nashville | Tennessee | United States | 37203 |
| 5 | Dallas Surgical | Dallas | Texas | United States | 75230 |
Sponsors and Collaborators
- Medneon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IGAP1000