UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062481 |
|---|---|
| Receipt number | R000071514 |
| Scientific Title | Prospective feasibility study of radial margin assessment as a nonserosal surgical margin in right-sided colon cancer |
| Date of disclosure of the study information | 2026/08/10 |
| Last modified on | 2026/08/05 16:59:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility study of radial margin assessment in right-sided colon cancer
Acronym
RIGHT-RM study
Scientific Title
Prospective feasibility study of radial margin assessment as a nonserosal surgical margin in right-sided colon cancer
Scientific Title:Acronym
RIGHT-RM study
Region
| Japan |
Condition
Condition
Right-sided colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of a specimen-processing method for pathological assessment of the radial margin as a nonserosal surgical margin in resected right-sided colon cancer specimens.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Success rate of pathological radial margin measurement
Key secondary outcomes
Radial margin distance, total number of examined lymph nodes, proportion of patients with at least 12 examined lymph nodes, pathological stage, specimen-processing time, and protocol deviation rate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older.
Patients diagnosed with, or clinically strongly suspected of having, adenocarcinoma of the cecum, ascending colon, hepatic flexure, or right transverse colon.
Patients scheduled to undergo ileocecal resection, right hemicolectomy, or extended right hemicolectomy with D2 or D3 lymph node dissection with curative intent.
Patients whose resected specimens can be processed according to the study protocol.
Key exclusion criteria
Patients scheduled to undergo clearly palliative or R2 resection.
Patients undergoing emergency surgery.
Tumors other than colorectal adenocarcinoma.
Colorectal cancer associated with a hereditary colorectal cancer syndrome or inflammatory bowel disease.
Patients whose pathological specimens are considered unsuitable for processing according to the study protocol before enrollment or before initiation of specimen processing.
Patients considered unsuitable for enrollment by the principal investigator or pathologist.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shunjin |
| Middle name | |
| Last name | Ryu |
Organization
Kawaguchi Municipal Medical Center
Division name
Department of Digestive Surgery
Zip code
333-0833
Address
180, Nishiaraijuku, Kawaguchi City, Saitama , Japan
TEL
048-287-2525
systematic.ryu1121@gmail.com
Public contact
Name of contact person
| 1st name | Shunjin |
| Middle name | |
| Last name | Ryu |
Organization
Kawaguchi Municipal Medical Center
Division name
Department of Digestive Surgery
Zip code
334-0011
Address
180, Nishiaraijuku, Kawaguchi City, Saitama , Japan
TEL
09080377438
Homepage URL
systematic.ryu1121@gmail.com
Sponsor or person
Institute
Kawaguchi Municipal Medical Center
Institute
Department
Personal name
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
Kawaguchi Municipal Medical Center
Address
180 Nishi-Araijuku, Kawaguchi, Saitama 333-0833, Japan
Tel
048-287-2525
systematic.ryu1121@gmail.com
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
| 2026 | Year | 08 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2032 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Eligible patients undergoing curative-intent resection for right-sided colon cancer will be consecutively enrolled in this prospective observational study. The success rate of pathological radial margin measurement will be evaluated. The effects on lymph node examination and pathological staging will also be compared with historical controls treated between January 1, 2022 and December 31, 2025. The target sample size of 50 refers to the prospective cohort and does not include the historical controls.
Management information
Registered date
| 2026 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071514
