NCT04531930Not yet recruiting
Colorectal Adenoma Canceration in FAP
Cohort Study on Colorectal Adenoma Canceration in Familial Adenomatous Polyposis
Source: ClinicalTrials.gov · Last updated 31 Aug 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The current internationally accepted treatment method for familial adenomatous polyposis is prophylactic total colorectal resection combined with endoscopic follow-up. However, total colorectal resection will bring a sharp decline in the quality of life of patients. Therefore, how to improve treatment methods and improve the quality of life for such patients under the premise of medical quality is the current medical focus. This study intends to establish three parallel observation cohorts, namely the surgical treatment group, the intensive colonoscopy treatment group, and the autonomous monitoring group. During the three-year study period, the investigators observed changes in the number of adenomas, carcinogenesis, and medical expenses in each group during the 3-year study period, and compared the groups to determine whether the intensive colonoscopy therapy has the possibility of delaying or replacing preventive surgery.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 124 (estimated)
- First submitted
- 26 Aug 2020
- Start date
- 1 Oct 2020
- Primary completion date
- 30 Sept 2023
- Lead sponsor
- Changhai Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT04531930
What you commit to
- Study type: Observational
- Planned participants: 124
- From 1 Oct 2020 to the primary completion date, 30 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The patient plans to receive surgical treatment of preventive colorectal resection;
Other illness
- Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients who need emergency surgical resection;
- Past history of colorectal surgery;
- Suffering from malignant tumors in other parts and requiring treatment or using chemotherapy drugs or NSAIDs;
- Patients or family members cannot understand the conditions and goals of this study;
Age
- Age \<18, or \>40 years old;
Other
- The initial number of polyps is \<100, or \>1000;
- The polyp has become cancerous or has suspected distant metastasis;
- The patient has contraindications to colonoscopy;
- Other reasons considered by the study doctor to be inappropriate for inclusion in the study.
Who the study is looking for
- The initial number of polyps is between 100-1000 visually;
- Pathological diagnosis of multiple lesions confirmed colorectal adenoma;
- Germline mutation detection is clearly a point mutation or large deletion of APC gene;
- No cancer or distant metastasis.
Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.