Genetics of Appendix Cancer Study

Appendix Cancer Clinical Trial

— GAP  

Official title:

Genetics of Appendix Cancer: The GAP Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734430
• Other study ID #: VICC GI 2280
• Status: Recruiting
• Start date: November 11, 2022
• Est. completion date: November 2034

Study information

• Verified date: April 2024
• Source: Vanderbilt-Ingram Cancer Center
• Contact: GAP Study Coordinator (Rebecca B.)
• Phone: 615-936-8544
• Email: gapcancerstudy[@]vumc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: November 2034
• Est. primary completion date: November 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma, Mucinous
• Appendiceal Adenocarcinoma
• Appendiceal Cancer
• Appendiceal Neoplasms
• Appendix Adenocarcinoma
• Appendix Cancer
• Appendix Tumor
• Carcinoid Tumor
• Cystadenocarcinoma
• Neoplasms
• Neoplasms, Cystic, Mucinous, and Serous

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Andreana Holowatyj, PhD, MSCI

Country where clinical trial is conducted

United States, 

References & Publications (1)

Holowatyj AN, Washington MK, Tavtigian SV, Eng C, Horton C. Inherited Cancer Susceptibility Gene Sequence Variations Among Patients With Appendix Cancer. JAMA Oncol. 2022 Nov 11;9(1):95-101. doi: 10.1001/jamaoncol.2022.5425. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence and spectrum of pathogenic and likely pathogenic germline variants in appendix cancer patients and their biological parents		Within 6 years of study enrollment
Secondary	Association of germline genetic variants with clinical, pathologic and molecular features of appendix tumors		Within 6 years of study enrollment

External Links

•   GAP Study Website