CancerNCT05171426
Incidental Cancer in Familial Adenomatous Polyposis
An observational study of Cancer, run by Dr. Ersin Arslan Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 20 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Familial Adenomatous Polyposis patients
Who may be able to join
- diagnosed with Familial Adenomatous Polyposis
Who cannot join
- did not receive surgical treatment
- data deficiencies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Ersin Arslan Training and Resource Hospital
Gaziantep
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Keywords
- familial adenomatous polyposis, colectomy, rectum, cancer, adenoma
- Medical subject headings
- Neoplasms, Adenomatous Polyposis Coli, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| incidental cancer | familial adenomatous polyposis with incidental cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidental cancer
Familial Adenomatous Polyposis with cancer
Measured: 2 or 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Jan 2018
- Primary completion15 Jan 2019
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ersin Arslan Education and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ufuk Uylas, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171426
- Sponsor's protocol ID
- 2018/16-20
- Status last verified
- Dec 2021
- First submitted
- 10 Dec 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidental Cancer in Colectomy Specimens From Patients With Familial Adenomatous Polyposis
- ClinicalTrials.gov ID
- NCT05171426
- Acronym / sponsor ID
- 2018/16-20
- Conditions
- Cancer
- Keywords
- familial adenomatous polyposis, colectomy, rectum, cancer, adenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Dr. Ersin Arslan Education and Training HospitalOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| incidental cancer | – | –familial adenomatous polyposis with incidental cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Familial Adenomatous Polyposis patients
Key inclusion criteria (1 listed)
- diagnosed with Familial Adenomatous Polyposis
Key exclusion criteria (2 listed)
- did not receive surgical treatment
- data deficiencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidental cancer
Time frame: 2 or 3 week
Familial Adenomatous Polyposis with cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Dr. Ersin Arslan Education and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidental cancer (time frame: 2 or 3 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.