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Trial record 3 of 73 for:    Appendix Cancer
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Genetics of Appendix Cancer Study (GAP)

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ClinicalTrials.gov Identifier: NCT05734430
Recruitment Status : Recruiting
First Posted : February 21, 2023
Last Update Posted : May 1, 2024
Sponsor:
Information provided by (Responsible Party):
Andreana Holowatyj, PhD, MSCI, Vanderbilt-Ingram Cancer Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment
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 Genetic: Genetic profiling Other: Retrospective tissue procurement

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetics of Appendix Cancer: The GAP Study
Actual Study Start Date : November 11, 2022
Estimated Primary Completion Date : November 2032
Estimated Study Completion Date : November 2034

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
GAP Social
Individuals ages 18+ years with an appendix cancer diagnosis in the United States.
 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
GAP Vanderbilt
Individuals ages 18+ years with an appendix cancer diagnosis seen at Vanderbilt.
 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
GAP Parent
Biological parents of active GAP (Social and Vanderbilt) Study participants.
 Genetic: Genetic profiling
Whole exome sequencing


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Association of germline genetic variants with clinical, pathologic and molecular features of appendix tumors [ Time Frame: Within 6 years of study enrollment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals age 18+ years diagnosed with appendix cancer, and biological parents of study participants.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05734430


Contacts
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Contact: GAP Study Coordinator (Rebecca B.) 615-936-8544 gapcancerstudy@vumc.org

Locations
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United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: GAP Study Coordinator (Rebecca B.)    615-936-8544    gapcancerstudy@vumc.org   
Principal Investigator: Andreana N Holowatyj, PhD, MSCI         
Sponsors and Collaborators
Andreana Holowatyj, PhD, MSCI
Investigators
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Principal Investigator: Andreana N Holowatyj, PhD, MSCI Vanderbilt-Ingram Cancer Center
More Information
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Additional Information:

Publications:

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Responsible Party: Andreana Holowatyj, PhD, MSCI, Sponsor Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT05734430    
Other Study ID Numbers: VICC GI 2280
First Posted: February 21, 2023    Key Record Dates
Last Update Posted: May 1, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreana Holowatyj, PhD, MSCI, Vanderbilt-Ingram Cancer Center:
Genetics
Additional relevant MeSH terms:
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Neoplasms
Carcinoid Tumor
Neoplasms, Cystic, Mucinous, and Serous
Appendiceal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Cecal Neoplasms
Intestinal Neoplasms
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Adenocarcinoma
Adenocarcinoma, Mucinous
Cystadenocarcinoma
Carcinoma
Digestive System Diseases
Gastrointestinal Diseases
Cecal Diseases
Intestinal Diseases