Genetics of Appendix Cancer Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-11

Study Completion Date

2034-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GAP Social

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

Genetic profiling

Intervention Type GENETIC

Whole exome sequencing

Retrospective tissue procurement

Intervention Type OTHER

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 profiling

Intervention Type GENETIC

Whole exome sequencing

Retrospective tissue procurement

Intervention Type OTHER

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 profiling

Intervention Type GENETIC

Whole exome sequencing

Interventions

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Genetic profiling

Whole exome sequencing

Intervention Type GENETIC

Retrospective tissue procurement

Collection of archived fixed-formalin, paraffin-embedded (FFPE) primary appendix tumor tissues that were previously removed

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes