NCT05171426

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

December 10, 2021

Last Update Submit

December 10, 2021

Conditions

Cancer

Keywords

familial adenomatous polyposiscolectomyrectumcanceradenoma

Outcome Measures

Primary Outcomes (1)

  • incidental cancer

    Familial Adenomatous Polyposis with cancer

    2 or 3 week

Study Arms (1)

incidental cancer

familial adenomatous polyposis with incidental cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Familial Adenomatous Polyposis patients

You may qualify if:

  • diagnosed with Familial Adenomatous Polyposis

You may not qualify if:

  • did not receive surgical treatment
  • data deficiencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Ersin Arslan Training and Resource Hospital

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsAdenomatous Polyposis ColiAdenoma

Condition Hierarchy (Ancestors)

Adenomatous PolypsNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesIntestinal PolyposisGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary investigator

Study Record Dates

First Submitted

December 10, 2021

First Posted

December 28, 2021

Study Start

January 1, 2018

Primary Completion

January 15, 2019

Study Completion

February 20, 2021

Last Updated

December 28, 2021

Record last verified: 2021-12

Locations

TU(1)