Clinical trial · Observational
Colorectal Adenoma Canceration in FAP
Cohort Study on Colorectal Adenoma Canceration in Familial Adenomatous Polyposis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Familial Adenomatous Polyposis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enhanced colonoscopy | Procedure | — | UNRESOLVED |
| self choosed methods | Other | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Surgery Group
- description
- Colorectal surgery
- interventionNames
- Procedure: surgery
- label
- Enhanced Colonoscopy Group
- description
- Enhanced colonoscopic treatment and surveillance
- interventionNames
- Procedure: enhanced colonoscopy
- label
- Self Choice Group
- description
- The patients choose the interventional methods, even do nothing.
- interventionNames
- Other: self choosed methods
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Age \<18, or \>40 years old; * The initial number of polyps is \<100, or \>1000; * The polyp has become cancerous or has suspected distant metastasis; * 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; * The patient has contraindications to colonoscopy; * Patients or family members cannot understand the conditions and goals of this study; * The patient plans to receive surgical treatment of preventive colorectal resection; * Other reasons considered by the study doctor to be inappropriate for inclusion in the study.
References
Publications (2)
- BACKGROUNDKarstensen JG, Burisch J, Pommergaard HC, Aalling L, Hojen H, Jespersen N, Schmidt PN, Bulow S. Colorectal Cancer in Individuals With Familial Adenomatous Polyposis, Based on Analysis of the Danish Polyposis Registry. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2294-2300.e1. doi: 10.1016/j.cgh.2019.02.008. Epub 2019 Feb 8. PMID 30743005
- BACKGROUNDBulow S. Results of national registration of familial adenomatous polyposis. Gut. 2003 May;52(5):742-6. doi: 10.1136/gut.52.5.742. PMID 12692062