The Informed Genetics Annotated Patient Registry

Predisposition, Genetic Clinical Trial

— iGAP  

Official title:

The Informed Genetics Annotated Patient Registry: The iGAP Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04419896
• Other study ID #: IGAP1000
• Status: Enrolling by invitation
• Start date: January 23, 2019
• Est. completion date: January 1, 2030

Study information

• Verified date: April 2022
• Source: Medneon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition to Disease
• Predisposition, Genetic

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medneon

Country where clinical trial is conducted

United States, 

Outcome

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