The Informed Genetics Annotated Patient Registry

NCT04419896 | Enrolling By Invitation

• 1 other identifier: IGAP1000
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Predisposition, Genetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing.

  10 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Medneon: lead

Study Sites (5)

North Valley Breast Clinic

Redding, California, 96001, United States

Location

Advocate Good Shepherd

Barrington, Illinois, 60010, United States

Location

Comprehensive Breast Care

Troy, Michigan, 48098, United States

Location

Nashville Breast Center

Nashville, Tennessee, 37203, United States

Location

Dallas Surgical

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 9, 2020
• Study Start: January 23, 2019
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

US (5)