UMIN-CTR Clinical Trial

Basic information
Public title	Study of appropriate CRM using preoperative MRI evaluation for cecal cancer and ascending colon cancer
Acronym	Study of appropriate CRM using preoperative MRI evaluation for cecal cancer and ascending colon cancer
Scientific Title	Study of appropriate CRM using preoperative MRI evaluation for cecal cancer and ascending colon cancer
Scientific Title:Acronym	Study of appropriate CRM using preoperative MRI evaluation for cecal cancer and ascending colon cancer
Region	Japan

Condition
Condition	Colon cancer
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to clarify the relationship between estimated CRM using MRI in colon cancer and pathological CRM in a novel specimen preparation method for colon cancer. Also, to prove that CRM assurance in colon cancer is useful for local control as well as remote control.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Match rate between estimated CRM and pathological CRM
Key secondary outcomes	Recurrence rate 3 years after surgery(peritoneal dissemination, local recurrence)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who have undergone colonoscopy and have been diagnosed with colorectal cancer or ascending colon cancer by endoscopy and fluoroscopy or CT or MRI. 2. Patients whose preoperative T factor can be diagnosed as deeper than T2 by endoscopy or CT. 3. Patients who can undergo R0 resection (curative resection) by laparotomy or laparoscopic surgery. 4. Patients aged 18 years or older at the time of consent acquisition. 5. Patients who have received sufficient explanation in participating in this study, and who have obtained sufficient understanding and voluntary written consent of the patient.
Key exclusion criteria	1. Patients with Stage IV with distant metastasis and peritoneal dissemination 2. Patients with double cancer 3. Patients with multiple cancers 4. Other patients who the principal investigator deems inappropriate for research
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Eguchi Middle name Last name Susumu
Organization	Nagasaki university
Division name	Department of Surgery
Zip code	8528102
Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL	0958197317
Email	sueguchi@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Adachi Middle name Last name Toshiyuki
Organization	Nagasaki university
Division name	Department of Surgery
Zip code	8528102
Address	1-7-1 Sakamoto, Nagasakai city, Nagasaki, Japan
TEL	0958197317
Homepage URL
Email	t-adachi@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki university hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki University Hospital Clinical Research Ethics Committee
Address	1-7-1 Sakamoto, Nagasakai city, Nagasaki, Japan
Tel	095-819-7726
Email	rinshou7726@umin.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 07 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2022 Year 06 Month 09 Day
Date of IRB	2022 Year 07 Month 12 Day
Anticipated trial start date	2022 Year 07 Month 13 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2022 Year 07 Month 13 Day
Last modified on	2022 Year 07 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055124