A Multicenter Randomized Controlled Trial Designed to Evaluate Follow-up Surveillance Strategies for Colorectal Cancer: The Japan Polyp Study

UMIN ID: C000000058

Registered date:12/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Colorectal Neoplasm
• Date of first enrollment: 2003/02/01
• Target sample size: 3000
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

1, 3 year follow-up after two complete colonoscopies with the removal of all polyps detected
3 year follow-up after two complete colonoscopies with the removal of all polyps detected

Outcome(s)

• Primary Outcome: The primary goal is to address the hypothesis that after two complete colonoscopies with the removal of all polyps detected, the incidence of clinically significant lesions would not be different between patients undergoing two further follow-up examinations and those undergoing just one. Clinically significant lesions are defined as index lesions (IL): if they are larger than 10mm; if they have high-grade dysplasia; or if they are invasive.
• Secondary Outcome: Colorectal cancer morbidity and mortality

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 69years-old
• Gender: Male and Female
• Exclude criteria: Patients who have a family or personal history of familial polyposis, HNPCC, inflammatory bowel disease, or a personal history of polypectomy with unknown histology, who have not had invasive colorectal cancer or colectomy have been considered for exnclusion.

Related Information

• Primary Sponsor: National Cancer Center Hospital (NCCH)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare, Japan