Genetics of Appendix Cancer Study

ConditionsAppendix 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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAndreana Holowatyj, PhD, MSCI

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Known diagnosis of appendix cancer in the United States

Mentally and physically able to consent and participate in the study

Known diagnosis of appendix cancer

Diagnosed by and/or consulting with a physician/clinical provider participating in the GAP Study

Disqualifiers

Women pregnant at the time of consent

Prisoners

Unable to provide informed consent

Unable to read, write, or complete questionnaires in English

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

700 Participants

are divided into 3 treatment groups

Group A: GAP Social2 interventions

Group B: GAP Vanderbilt2 interventions

Group C: GAP Parent1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

Association of germline genetic variants with clinical, pathologic and molecular features of appendix tumors

Time frame

Within 6 years of study enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Andreana Holowatyj, PhD, MSCI

Lead sponsor

Vanderbilt-Ingram Cancer Center

Sponsor institution

Source ClinicalTrials.gov

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