Colorectal Adenoma Canceration in FAP

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ClinicalTrials.gov Identifier: NCT04531930

Recruitment Status : Not yet recruiting

First Posted : August 31, 2020

Last Update Posted : August 31, 2020

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Sponsor:

Information provided by (Responsible Party):

En-Da Yu, Changhai Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Familial Adenomatous Polyposis	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 Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	124 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Target Follow-Up Duration:	10 Years
Official Title:	Cohort Study on Colorectal Adenoma Canceration in Familial Adenomatous Polyposis
Estimated Study Start Date :	October 1, 2020
Estimated Primary Completion Date :	September 30, 2023
Estimated Study Completion Date :	September 30, 2030

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial adenomatous polyposis

Genetic and Rare Diseases Information Center resources: Familial Adenomatous Polyposis MYH-associated Polyposis

U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

3yCR [ Time Frame: 3 years ]
3 year Cancerous rate

Secondary Outcome Measures :

Adenoma number Change [ Time Frame: 3 years ]
Change of adenoma number by 3 years
3yOSR [ Time Frame: 3 years ]
3 year overall survival rate

Biospecimen Retention: Samples With DNA

peripheral blood and adenoma samples

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531930

Contacts

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Contact: En-Da YU, MBBS	8613901688626	endayu@yeah.net

Locations

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

Sponsors and Collaborators

Changhai Hospital

Investigators

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Principal Investigator:	Jun-Jie XING, MD	Changhai Hospital

More Information

Publications:

Karstensen JG, Burisch J, Pommergaard HC, Aalling L, Højen H, Jespersen N, Schmidt PN, Bülow 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.

Bülow S. Results of national registration of familial adenomatous polyposis. Gut. 2003 May;52(5):742-6.

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Responsible Party:	En-Da Yu, Professor, Changhai Hospital
ClinicalTrials.gov Identifier:	NCT04531930
Other Study ID Numbers:	SINOFAP2020A
First Posted:	August 31, 2020 Key Record Dates
Last Update Posted:	August 31, 2020
Last Verified:	August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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

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