UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057129 |
|---|---|
| Receipt number | R000065300 |
| Scientific Title | Evaluation of the Diagnostic Accuracy of Cancer Screening Using the Nematode C. elegans (N-NOSE) for Colorectal Advanced Neoplasia: A Pilot Study |
| Date of disclosure of the study information | 2025/02/25 |
| Last modified on | 2025/02/25 17:31:07 |
* 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
Evaluation of the Diagnostic Accuracy of Cancer Screening Using the Nematode C. elegans (N-NOSE) for Colorectal Advanced Neoplasia: A Pilot Study
Acronym
Evaluation of the Diagnostic Accuracy of Cancer Screening Using the Nematode C. elegans (N-NOSE) for Colorectal Advanced Neoplasia: A Pilot Study
Scientific Title
Evaluation of the Diagnostic Accuracy of Cancer Screening Using the Nematode C. elegans (N-NOSE) for Colorectal Advanced Neoplasia: A Pilot Study
Scientific Title:Acronym
Evaluation of the Diagnostic Accuracy of Cancer Screening Using the Nematode C. elegans (N-NOSE) for Colorectal Advanced Neoplasia: A Pilot Study
Region
| Japan |
Condition
Condition
Early colorectal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The study population consists of patients with suspected early-stage colorectal cancer scheduled for endoscopic treatment, while the control group comprises individuals who underwent colonoscopy but had no detected polyps. The N-NOSE index will be measured in both groups, and its diagnostic accuracy for early-stage colorectal cancer will be evaluated by comparing the N-NOSE index between the two groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensitivity and specificity of N-NOSE for early-stage colorectal cancer.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Early-stage Colorectal Cancer Group: Patients who are hospitalized or receiving outpatient care at the Division of Gastroenterology, Showa University Hospital, and have been diagnosed with early-stage colorectal cancer eligible for endoscopic treatment.
Control Group: Patients who are hospitalized or receiving outpatient care at the Division of Gastroenterology, Showa University Hospital, and have been confirmed to have no adenomatous polyps during screening colonoscopy.
Age Requirement: Patients who are 20 years or older at the time of consent acquisition.
Informed Consent: Patients who have provided written informed consent for participation in this study.
Key exclusion criteria
Patients with Concurrent Malignancies Other than Early-Stage Colorectal Cancer
Patients with a History of Other Organ Cancers
Patients Deemed Ineligible by the Principal Investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | KAZUYA |
| Middle name | |
| Last name | INOKI |
Organization
Department of Medicine, Showa University School of Medicine,
Division name
Division of Gastroenterology
Zip code
1428666
Address
1-5-8, Hatanodai, Shinagawaku, Tokyo 142-8666, Japan
TEL
0337848535
kinoki@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | KAZUYA |
| Middle name | |
| Last name | INOKI |
Organization
Department of Medicine, Showa University School of Medicine
Division name
Division of Gastroenterology
Zip code
1428666
Address
1-5-8, Hatanodai, Shinagawaku, Tokyo 142-8666, Japan
TEL
0337848535
Homepage URL
kinoki@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Research Administration Center
Address
1-5-8, Hatanodai, Shinagawaku, Tokyo 142-8555, Japan
Tel
03-3784-8863
surac1@ofc.showa-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 | 02 | Month | 25 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To date, the diagnostic accuracy of N-NOSE for colorectal advanced neoplasia, including early-stage colorectal cancer eligible for endoscopic treatment, has been evaluated.Urine samples will be appropriately managed and sent to HIROTSU Bioscience for N-NOSE measurement. The N-NOSE index will be compared between patients with and without advanced neoplasia.
Management information
Registered date
| 2025 | Year | 02 | Month | 25 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065300
