Genetics of Appendix Cancer Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05734430
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Andreana Holowatyj, PhD, MSCI
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Andreana N Holowatyj, PhD, MSCI
Principal Investigator Affiliation Vanderbilt-Ingram Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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 Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: GAP Social

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

: GAP Vanderbilt

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

: GAP Parent

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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232

Site Contact

GAP Study Coordinator (Rebecca B.)

[email protected]

615-936-8544

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