Predisposition, Genetic Clinical Trial
— iGAPOfficial title:
The Informed Genetics Annotated Patient Registry: The iGAP Registry
Verified date | April 2022 |
Source | Medneon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Enrolling by invitation |
Enrollment | 10000 |
Est. completion date | January 1, 2030 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Advocate Good Shepherd | Barrington | Illinois |
United States | Dallas Surgical | Dallas | Texas |
United States | Nashville Breast Center | Nashville | Tennessee |
United States | North Valley Breast Clinic | Redding | California |
United States | Comprehensive Breast Care | Troy | Michigan |
Lead Sponsor | Collaborator |
---|---|
Medneon |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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