Colorectal Adenoma Canceration in FAP

Launched by CHANGHAI HOSPITAL · Aug 28, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at new ways to manage a condition called Familial Adenomatous Polyposis (FAP), which causes many polyps (growths) in the colon that can lead to cancer. The usual treatment involves removing the entire colon, but this can significantly lower patients' quality of life. Researchers want to see if a different approach, which includes regular colon check-ups and monitoring, can help delay or even replace the need for surgery. They will compare three groups: one that has surgery, one that receives intensive monitoring through colonoscopy (a procedure to look inside the colon), and another that monitors their condition independently.

To be eligible for the trial, participants should generally be between 6574 and 14609 years old and have a specific number of polyps (between 100 and 1000) with a confirmed diagnosis of colorectal adenoma. They must also have a genetic mutation related to this condition and not have cancer or any spread of disease. Throughout the three years of the study, participants will have their polyp counts, cancer risk, and medical costs monitored to see how well each treatment approach works. If you or a loved one is considering participating, you can expect regular check-ups and support from the research team to help understand the process and goals of the study.

Gender

ALL

Eligibility 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.