臨床研究等提出・公開システム

Scientific Title	Feasibility for consensus molecular subtype classification of colorectal cancer using preoperative biopsy tissues; A pilot study
Public Title	COLLAB study

Contact for Scientific Queries	Name	Shiomi Akio
	Affiliation	Shizuoka Cancer Center
	Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
	Telephone	+81-55-989-5222
	E-mail	a.shiomi@scchr.jp
Contact for Public Queries	Name	Kasai Shunsuke
	Affiliation	Shizuoka Cancer Center
	Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
	Telephone	+81-55-989-5222
	E-mail	s.kasai@scchr.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		April. 23, 2025
Actual date of first enrollment		June. 02, 2025
Target sample size		8
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients 18 years and older with PS (ECOG) of 0 or1. (2) Patients with primary colorectal cancer deeper than cT2.
	Exclusion Criteria	(1) Patients with a history of chemotherapy or radiotherapy, including treatment for other cancers. (2) Patients taking antiplatelet or anticoagulant medications.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Primary colorectal cancer
Intervention(s)		Two types of biopsy forceps of different sizes (EndoJaw (FB-220U, OLYMPUS) / EndoJaw Jumbo (FB-214U, OLYMPUS)) are used to collect one additional tissue at each location during preoperative colonoscopy.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Percentage of tissue collected using two types of biopsy forceps during preoperative colonoscopy that can be classified as CMS
Secondary Outcome(s)		(1) Comparison of CMS classification by tissue collection site using two types of biopsy forceps (2) Adverse events

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Shizuoka Cancer Center Certified Review Board
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
Telephone	+81-55-989-5222
E-Mail	rinsho_office@scchr.jp
Approval Status	Approval
Date of approval	Mar. 31, 2025

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history