Colorectal Adenoma Canceration in FAP

NCT04531930 | Not Yet Recruiting

• 1 other identifier: SINOFAP2020A
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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

Familial Adenomatous Polyposis

Outcome Measures

Primary Outcomes (1)

• 3yCR

  3 year Cancerous rate

  3 years

Secondary Outcomes (2)

• Adenoma number Change

  3 years

• 3yOSR

  3 years

Study Arms (3)

Surgery Group

Colorectal surgery

Procedure: surgery

Enhanced Colonoscopy Group

Enhanced colonoscopic treatment and surveillance

Procedure: enhanced colonoscopy

Self Choice Group

The patients choose the interventional methods, even do nothing.

Other: self choosed methods

Interventions

surgery PROCEDURE

Colorectal surgery, mainly total proctocolectomy.

Surgery Group

enhanced colonoscopy PROCEDURE

Colonoscopic treatment and surveillance in every 3 months.

Enhanced Colonoscopy Group

self choosed methods OTHER

A patient chooses a method for himself other than surgery.

Self Choice Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (2)

• 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.

  PMID: 30743005 BACKGROUND

• Bulow 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood and adenoma samples

MeSH Terms

Conditions

Adenomatous Polyposis Coli

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Adenomatous Polyps; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyposis; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jun-Jie XING, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

En-Da YU, MBBS

CONTACT

8613901688626; endayu@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2023
• Study Completion (Estimated): September 30, 2030
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)