UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058110 |
|---|---|
| Receipt number | R000066388 |
| Scientific Title | Identification of gut microbiome biomarkers for early detection of colorectal cancer in middle-aged adults: an exploratory 16S rRNA sequencing study |
| Date of disclosure of the study information | 2025/06/06 |
| Last modified on | 2025/06/06 18:08:21 |
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Basic information
Public title
Early detection of colorectal cancer using gut flora in adults aged 40-60
Acronym
GutCRC Study
Scientific Title
Identification of gut microbiome biomarkers for early detection of colorectal cancer in middle-aged adults: an exploratory 16S rRNA sequencing study
Scientific Title:Acronym
GutCRC-16S
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate in detail the relationship between early-stage colorectal cancer and the gut microbiome in middle-aged adults, and to establish a gut-microbiome-based assay capable of detecting colorectal cancer (including early lesions) with high sensitivity and specificity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of the gut-microbiome assay for colorectal cancer (including early lesions): sensitivity and specificity
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with a confirmed diagnosis of colorectal cancer who are scheduled to undergo colonoscopy as part of routine clinical care at the time of diagnosis or thereafter.
* If the patient has already undergone colonoscopy, the diagnosis is definitive, and no further examinations are required, only the results from that prior colonoscopy will be used.
* If a repeat colonoscopy is performed (e.g., for pre-operative assessment), the findings from the repeat examination will be used as study data.
2. Genetically Japanese individuals.
3. Age: 40 - 65 years at the time of enrollment.
4. Performance Status (ECOG): 0, 1, or 2.
5. **Written informed consent** obtained from the patient after adequate explanation of the study.
Key exclusion criteria
1. Pregnant or breastfeeding individuals.
2. Subjects who have difficulty with spontaneous defecation and require laxatives, enemas, or similar interventions.
3. Patients with severe dysfunction or failure of a major organ (heart, lung, liver, kidney, or bone marrow).
4. Patients with inflammatory bowel disease (IBD) or familial adenomatous polyposis.
5. Patients with a history of colorectal surgery, excluding appendectomy.
6. Individuals who have used antibiotics within the past three months.
7. Individuals judged by the principal or sub-investigator to be unsuitable for participation in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | TADATERU |
| Middle name | |
| Last name | MAEHATA |
Organization
St. Marianna University School of Medicine
Division name
Department of Gastroenterology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-977-8111
t2maehata@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | TADATERU |
| Middle name | |
| Last name | MAEHATA |
Organization
St. Marianna University School of Medicine
Division name
Department of Gastroenterology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
t2maehata@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine Ethics Review Committee
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-u.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
| 2025 | Year | 06 | Month | 06 | 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
| 2025 | Year | 04 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exposure and Outcome
Association between a stool-based gut-microbiome risk score derived from 16S rRNA sequencing (exposure) and the presence or absence of colorectal cancer-including early lesions-confirmed by diagnostic colonoscopy (outcome).
Study design
Prospective cross-sectional observational study. Stool samples are collected at enrollment, and the clinically indicated colonoscopy performed during the same period serves as the reference standard.
Sampling
Consecutive enrollment of patients aged 40-65 years with colorectal cancer (100 early-stage and 100 advanced-stage cases)
Primary analysis Estimation of sensitivity and specificity.
Secondary analyses Gut-microbiome alpha/beta diversity, comparison with the fecal immunochemical test, etc.
Target sample size 200 cases of colorectal cancer (100 early, 100 advanced)
Site St. Marianna University School of Medicine Hospital (single-center).
Management information
Registered date
| 2025 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066388
