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Trial Title:
Genetics of Appendix Cancer Study
NCT ID:
NCT05734430
Condition:
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
Conditions: Official terms:
Neoplasms
Adenocarcinoma
Carcinoid Tumor
Adenocarcinoma, Mucinous
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Appendiceal Neoplasms
Conditions: Keywords:
Genetics
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
Genetic profiling
Description:
Whole exome sequencing
Arm group label:
GAP Parent
Arm group label:
GAP Social
Arm group label:
GAP Vanderbilt
Intervention type:
Other
Intervention name:
Retrospective tissue procurement
Description:
Collection of archived fixed-formalin, paraffin-embedded (FFPE) primary appendix tumor
tissues that were previously removed
Arm group label:
GAP Social
Arm group label:
GAP Vanderbilt
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Individuals age 18+ years diagnosed with appendix cancer, and biological parents of study
participants.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Vanderbilt-Ingram Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
GAP Study Coordinator (Rebecca B.)
Phone:
615-936-8544
Email:
gapcancerstudy@vumc.org
Investigator:
Last name:
Andreana N Holowatyj, PhD, MSCI
Email:
Principal Investigator
Start date:
November 11, 2022
Completion date:
November 2034
Lead sponsor:
Agency:
Andreana Holowatyj, PhD, MSCI
Agency class:
Other
Source:
Vanderbilt-Ingram Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05734430
https://www.gapcancerstudy.org
