The Informed Genetics Annotated Patient Registry (iGAP)

The Informed Genetics Annotated Patient Registry: The iGAP 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Predisposition, Genetic

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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• United States
  • California
    • Redding, California, United States, 96001
      • North Valley Breast Clinic
  • Illinois
    • Barrington, Illinois, United States, 60010
      • Advocate Good Shepherd
  • Michigan
    • Troy, Michigan, United States, 48098
      • Comprehensive Breast Care
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Nashville Breast Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Surgical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medneon

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 23, 2019
• Primary Completion (ANTICIPATED): January 1, 2025
• Study Completion (ANTICIPATED): January 1, 2030

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: IGAP1000

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No