UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062974 |
|---|---|
| Receipt number | R000072101 |
| Scientific Title | A cohort study to optimize endoscopic surveillance for metachronous colorectal cancer after surgical resection of colorectal cancer |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/18 12:44:53 |
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Basic information
Public title
A study of colonoscopic surveillance for the early detection of new colorectal cancer after colorectal cancer surgery
Acronym
OPTISURV-CRC Study
Scientific Title
A cohort study to optimize endoscopic surveillance for metachronous colorectal cancer after surgical resection of colorectal cancer
Scientific Title:Acronym
OPTISURV-CRC Study
Region
| Japan |
Condition
Condition
Colorectal cancer after surgical resection
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the incidence of metachronous colorectal cancer after colorectal cancer surgery and to investigate its association with synchronous colorectal neoplasms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of metachronous colorectal cancer (incidence, time to occurrence, tumor location, tumor size, morphology, and histological type)
Key secondary outcomes
1. Occurrence of anastomotic recurrence (incidence proportion, time to recurrence, morphology, and histological type)
2. Presence of synchronous colorectal cancer
3. Presence of synchronous colorectal adenomas
4. Presence of synchronous advanced lesions
5. Subgroup analyses of the incidence proportion of metachronous colorectal cancer according to age, sex, presence or absence of synchronous colorectal cancer, synchronous colorectal adenomas, and synchronous advanced lesions, stage of the primary colorectal cancer, and participating hospital
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent curative surgical resection (R0 resection) for primary colorectal cancer at Fukushima Medical University Aizu Medical Center Hospital or Jichi Medical University Hospital between September 2015 and August 2021.
Key exclusion criteria
1. Patients with Stage IV colorectal cancer (distant metastasis present at the time of surgery)
2. Patients with a synchronous malignancy in an organ other than the colorectum at the time of colorectal cancer surgery
3. Patients with known hereditary colorectal cancer syndromes, such as Lynch syndrome or familial adenomatous polyposis (FAP)
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Kazutomo |
| Middle name | |
| Last name | Togashi |
Organization
Fukushima Medical University
Division name
Aizu Medical Center
Zip code
969-3492
Address
21-2 Maeda, Yazawa, Kawahigashi-machi, Aizuwakamatsu, Fukushima, Japan
TEL
0242752100
togashik@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kakeru |
| Middle name | |
| Last name | Otomo |
Organization
Fukushima Medical University
Division name
Aizu Medical Center
Zip code
969-3492
Address
21-2 Maeda, Yazawa, Kawahigashi-machi, Aizuwakamatsu, Fukushima, Japan
TEL
0242752100
Homepage URL
be59733a@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jichi Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, Fukushima, Japan
Tel
0245471825
fmurec@fmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
REC2026-112
Org. issuing International ID_1
Ethics Committee of Fukushima Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福島県立医科大学会津医療センター（福島県）、自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | 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 | 09 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of the Primary Outcome:
Descriptive statistics will be used to summarize the occurrence of metachronous colorectal cancer, including the incidence proportion, time to occurrence, tumor location, tumor size, morphology, and histological type. The incidence proportion will be reported with its exact 95% confidence interval. The cumulative incidence of metachronous colorectal cancer will be estimated using the cumulative incidence function (CIF), with death treated as a competing risk. Recurrence-free survival will be estimated using the Kaplan-Meier method.
Management information
Registered date
| 2026 | Year | 09 | Month | 18 | Day |
Last modified on
| 2026 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072101
