Genetics of Appendix Cancer Study

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Andreana Holowatyj, PhD, MSCI
Study ID
NCT05734430
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Genetic profiling — GENETIC
    Whole exome sequencing
  • Retrospective tissue procurement — OTHER
    Collection of archived fixed-formalin, paraffin-embedded (FFPE) primary appendix tumor tissues that were previously removed

Study Details

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.

Key Dates

Start date
Nov 11, 2022
Status verified
Apr 2025
Primary completion
Nov 30, 2032
Completion
Nov 30, 2034

Study Design

Enrollment
700 participants (estimated)

Arms

  • Arm: GAP Social
    Individuals ages 18+ years with an appendix cancer diagnosis in the United States.
  • Arm: GAP Vanderbilt
    Individuals ages 18+ years with an appendix cancer diagnosis seen at Vanderbilt.
  • Arm: GAP Parent
    Biological parents of active GAP (Social and Vanderbilt) Study participants.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232
GAP Study Coordinator (Rebecca B.)
615-936-8544
Andreana N Holowatyj, PhD, MSCI (PRINCIPAL_INVESTIGATOR)

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