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The Informed Genetics Annotated Patient Registry (iGAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04419896
Recruitment Status : Enrolling by invitation
First Posted : June 9, 2020
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
Medneon

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
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: The Informed Genetics Annotated Patient Registry: The iGAP Registry
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2030

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.



Primary Outcome Measures :
  1. To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings. [ Time Frame: 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 :
  1. To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing. [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419896


Locations
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United States, California
North Valley Breast Clinic
Redding, California, United States, 96001
United States, Illinois
Advocate Good Shepherd
Barrington, Illinois, United States, 60010
United States, Michigan
Comprehensive Breast Care
Troy, Michigan, United States, 48098
United States, Tennessee
Nashville Breast Center
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas Surgical
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Medneon
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Responsible Party: Medneon
ClinicalTrials.gov Identifier: NCT04419896    
Other Study ID Numbers: IGAP1000
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes