- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05171426
Incidental Cancer in Familial Adenomatous Polyposis
December 10, 2021 updated by: Ufuk Uylas, Dr. Ersin Arslan Education and Training Hospital
Incidental Cancer in Colectomy Specimens From Patients With Familial Adenomatous Polyposis
Colectomy is life-saving in patients with familial adenomatous polyposis (FAP) because cancer development is inevitable in individuals with this disease.
In this study, we aimed to determine the incidence of incidental malignancy in surgical specimens from patients who underwent colectomy for FAP.
Prophylactic colectomy should be performed in patients with FAP, as colorectal cancer transformation is inevitable in these individuals.
The possibility of incidental cancer identified via histopathological analysis of colectomy specimens should be kept in mind in these patients.
Study Overview
Status
Completed
Conditions
Detailed Description
Colectomy is life-saving in patients with familial adenomatous polyposis (FAP) because cancer development is inevitable in individuals with this disease.
In this study, we aimed to determine the incidence of incidental malignancy in surgical specimens from patients who underwent colectomy for FAP.
The files of patients diagnosed with FAP who underwent surgery in our clinic between 2010 and 2020 were retrospectively reviewed.
Definitive surgery was performed in patients with histopathological malignancy identified in colonoscopic biopsies in the preoperative period, while prophylactic surgery was performed in patients without malignancy.
The incidence of incidental malignancy in histopathological specimens from patients who underwent prophylactic colectomy was determined.
Prophylactic colectomy should be performed in patients with FAP, as colorectal cancer transformation is inevitable in these individuals.
The possibility of incidental cancer identified via histopathological analysis of colectomy specimens should be kept in mind in these patients.
Study Type
Observational
Enrollment (Actual)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gaziantep, Turkey
- Dr. Ersin Arslan Training and Resource Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Familial Adenomatous Polyposis patients
Description
Inclusion Criteria:
- diagnosed with Familial Adenomatous Polyposis
Exclusion Criteria:
- did not receive surgical treatment
- data deficiencies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
incidental cancer
familial adenomatous polyposis with incidental cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidental cancer
Time Frame: 2 or 3 week
|
Familial Adenomatous Polyposis with cancer
|
2 or 3 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
January 15, 2019
Study Completion (Actual)
February 20, 2021
Study Registration Dates
First Submitted
December 10, 2021
First Submitted That Met QC Criteria
December 10, 2021
First Posted (Actual)
December 28, 2021
Study Record Updates
Last Update Posted (Actual)
December 28, 2021
Last Update Submitted That Met QC Criteria
December 10, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Neoplastic Syndromes, Hereditary
- Adenomatous Polyps
- Adenoma
- Intestinal Polyposis
- Adenomatous Polyposis Coli
Other Study ID Numbers
- 2018/16-20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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