Genetics of Appendix Cancer Study (GAP)

Andreana Holowatyj, PhD, MSCI

Status: Enrolling

Conditions: Appendix Adenocarcinoma; Appendiceal Carcinoid Tumor; Appendiceal Neoplasm Malignant Secondary; Appendiceal Neoplasms; Appendix Cancer; Appendix NET; High Grade Appendix Mucinous Adenocarcinoma; Appendix Cancer Metastatic; Appendix Mucinous Neoplasm; Appendiceal Mucinous Neoplasm; Appendiceal Adenocarcinoma; Appendix Tumor; Appendiceal Cancer; High Grade Appendix Mucinous Neoplasm; Low-Grade Appendix Mucinous Neoplasm

Treatments: Genetic: Genetic profiling; Other: Retrospective tissue procurement

Study type: Observational

Funder types: Other

Identifiers

NCT05734430

VICC GI 2280

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

700 participants in 3 patient groups

GAP Social

Description:

Individuals ages 18+ years with an appendix cancer diagnosis in the United States.

Treatment:

Other: Retrospective tissue procurement

Genetic: Genetic profiling

GAP Vanderbilt

Description:

Individuals ages 18+ years with an appendix cancer diagnosis seen at Vanderbilt.

Treatment:

Other: Retrospective tissue procurement

Genetic: Genetic profiling

GAP Parent

Description:

Biological parents of active GAP (Social and Vanderbilt) Study participants.

Treatment:

Genetic: Genetic profiling