Colorectal Adenoma Canceration in FAP

Cohort Study on Colorectal Adenoma Canceration in Familial Adenomatous Polyposis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Familial Adenomatous Polyposis
• Intervention / Treatment: Procedure: surgery; Procedure: enhanced colonoscopy; Other: self choosed methods

Detailed Description

Familial adenomatous polyposis is a kind of colorectal cancer syndrome, which belongs to rare diseases. It is estimated that the number of patients in China is about 100,000, accounting for about 1% of all colorectal cancer patients. This type of patients onset between the ages of ten and thirty years old. The typical manifestation is the growth of tens to thousands of colorectal adenomas, and the lifetime risk of colorectal cancer is close to 100%, accompanied by multiple extraintestinal manifestations . Without treatment, the average life span is 40-50 years. The current internationally accepted treatment method is prophylactic total colorectal resection combined with endoscopic follow-up. This program has a significant effect and can extend life expectancy by 10-20 years. However, total colorectal resection will bring a sharp decline in the quality of life of patients. The patients will lose many abilities (working ability, social ability, fertility, etc.) from the age of 20, and the prolonged survival period also brings more misery. This, in turn, also reduces the compliance of treatment. Many patients refuse to accept surgery and turn to endoscopic treatment or even give up treatment. However, there is currently no evidence that methods other than prophylactic surgery can effectively control the risk of colorectal cancer in such 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. Among them, the intensive colonoscopy treatment group will be treated with colonoscopy intensive treatment (that is, colonoscopy treatment is performed every 3 months, Carry out colorectal tumor reduction in segments, and continue to control the growth of adenomas several times) for patients who refuse surgery. 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, so as to explore ways to improve the quality of life of such patients.

• Study Type: Observational
• Enrollment (Anticipated): 124

Contacts and Locations

• Study Contact: Name: En-Da YU, MBBS; Phone Number: 8613901688626; Email: endayu@yeah.net

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The anticipants will be allocated in one of the three groups, and accept the corresponding intervention and at least 3 year follow up.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery Group; Colorectal surgery	Procedure: surgery; Colorectal surgery, mainly total proctocolectomy.
Enhanced Colonoscopy Group; Enhanced colonoscopic treatment and surveillance	Procedure: enhanced colonoscopy; Colonoscopic treatment and surveillance in every 3 months.
Self Choice Group; The patients choose the interventional methods, even do nothing.	Other: self choosed methods; A patient chooses a method for himself other than surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3yCR	3 year Cancerous rate	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma number Change	Change of adenoma number by 3 years	3 years
3yOSR	3 year overall survival rate	3 years

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Jun-Jie XING, MD, Changhai Hospital

Publications and helpful links

General Publications

• Karstensen 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.
• Bulow S. Results of national registration of familial adenomatous polyposis. Gut. 2003 May;52(5):742-6. doi: 10.1136/gut.52.5.742.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2030

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 28, 2020
• Last Verified: August 1, 2020

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; Intestinal Polyposis; Adenoma; Adenomatous Polyposis Coli
• Other Study ID Numbers: SINOFAP2020A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No