Genetics of Appendix Cancer Study (GAP)

April 29, 2024 updated by: Andreana Holowatyj, PhD, MSCI

Genetics of Appendix Cancer: The GAP Study

The GAP Study is a prospective cohort study designed to comprehensively investigate genetic variations that may contribute to cancer development among individuals diagnosed with appendix/appendiceal cancer who are ages 18+ years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Genetics of Appendix Cancer (GAP) Study aims to analyze hereditary factors, tumor characteristics and clinical features/outcomes among adults diagnosed with appendix cancer and their biological parents. Patients are recruited at any time after a diagnosis of appendix cancer and followed for up to 6 years after study enrollment. This cohort is enriched by robust biospecimens and data collections.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt-Ingram Cancer Center
        • Principal Investigator:
          • Andreana N Holowatyj, PhD, MSCI
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Individuals age 18+ years diagnosed with appendix cancer, and biological parents of study participants.

Description

Inclusion Criteria:

GAP Social

  • Known diagnosis of appendix cancer in the United States
  • Mentally and physically able to consent and participate in the study

GAP Vanderbilt

  • Known diagnosis of appendix cancer
  • Diagnosed by and/or consulting with a physician/clinical provider participating in the GAP Study
  • Mentally and physically able to consent and participate in the study

GAP Parent

  • Biological parents (mother and/or father) of individuals actively participating in the GAP Study
  • Residing in the United States
  • Mentally and physically able to consent and participate in the study

Exclusion Criteria:

  • Women pregnant at the time of consent
  • Prisoners
  • Unable to provide informed consent
  • Unable to read, write, or complete questionnaires in English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GAP Social
Individuals ages 18+ years with an appendix cancer diagnosis in the United States.
Genetic: Genetic profiling
Whole exome sequencing
Other: Retrospective tissue procurement
Collection of archived fixed-formalin, paraffin-embedded (FFPE) primary appendix tumor tissues that were previously removed
GAP Vanderbilt
Individuals ages 18+ years with an appendix cancer diagnosis seen at Vanderbilt.
Genetic: Genetic profiling
Whole exome sequencing
Other: Retrospective tissue procurement
Collection of archived fixed-formalin, paraffin-embedded (FFPE) primary appendix tumor tissues that were previously removed
GAP Parent
Biological parents of active GAP (Social and Vanderbilt) Study participants.
Genetic: Genetic profiling
Whole exome sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence and spectrum of pathogenic and likely pathogenic germline variants in appendix cancer patients and their biological parents
Time Frame: Within 6 years of study enrollment
Within 6 years of study enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Association of germline genetic variants with clinical, pathologic and molecular features of appendix tumors
Time Frame: Within 6 years of study enrollment
Within 6 years of study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andreana Holowatyj, PhD, MSCI

Investigators

  • Principal Investigator: Andreana N Holowatyj, PhD, MSCI, Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2022

Primary Completion (Estimated)

November 1, 2032

Study Completion (Estimated)

November 1, 2034

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC GI 2280

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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