UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058699 |
|---|---|
| Receipt number | R000067113 |
| Scientific Title | Integrative Analysis of Circulating Tumor DNA and Digital Pathology Score for Postoperative Risk Assessment in Colorectal Cancer |
| Date of disclosure of the study information | 2025/08/05 |
| Last modified on | 2025/08/05 13:47:41 |
* 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
Integrative Analysis of Circulating Tumor DNA and Digital Pathology Score for Postoperative Risk Assessment in Colorectal Cancer
Acronym
Integrative Analysis of Circulating Tumor DNA and Digital Pathology Score for Postoperative Risk Assessment in Colorectal Cancer
Scientific Title
Integrative Analysis of Circulating Tumor DNA and Digital Pathology Score for Postoperative Risk Assessment in Colorectal Cancer
Scientific Title:Acronym
Histotyping in MONSTAR-3
Region
| Japan | Europe |
Condition
Condition
Malignant solid tumors
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Nephrology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery | Obstetrics and Gynecology |
| Dermatology | Oto-rhino-laryngology | Orthopedics |
| Urology | Radiology | Oral surgery |
| Neurosurgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the prognostic and lymph node metastasis prediction performance of the combination of blood circulating tumor DNA (ctDNA) status and digital pathology score using deep learning in colorectal cancer patients who have undergone radical surgical treatment (including radical surgical treatment after local resection).
Basic objectives2
Others
Basic objectives -Others
This study aims to refine a recurrence and lymph node metastasis risk prediction model integrating ctDNA MRD with Histotyping by performing digital Histotyping analysis of tumor specimens from colorectal cancer patients enrolled in the resectable cohort of the MONSTAR-SCREEN-3 trial, and evaluating the association between the integrated biomarker of ctDNA MRD and Histotyping with clinical outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time-to-recurrence (TTR) in prognostic models using ctDNA and Histotyping.
Diagnostic concordance for lymph node metastasis in prediction models using ctDNA and Histotyping.
Key secondary outcomes
Association between ctDNA, Histotyping score and efficacy of adjuvant therapy.
Correlation between Histotyping and clinical outcomes including disease-free survival (DFS), overall survival (OS), and ctDNA positivity, as well as their associations with other clinicopathological and molecular biological features and perioperative treatments
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
Colorectal cancer patients undergoing radical surgical treatment enrolled in the MONSTAR-SCREEN-3 study (cohort B) who have not withdrawn consent or refused secondary use of their samples and information.
Key exclusion criteria
Data required for this study are missing.
Cases for which the principal investigator determines that enrollment in this study is inappropriate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department for the Promotion of Drug and Diagnostic Development
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Tadayoshi |
| Middle name | |
| Last name | Hashimoto |
Organization
National Cancer Center Hospital East
Division name
Department for the Promotion of Drug and Diagnostic Development
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
Homepage URL
tadhashi@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Oslo University Hospital,University of Oxford
Name of secondary funder(s)
Oslo University Hospital,University of Oxford
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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 | 08 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the prognostic and lymph node metastasis prediction performance of the combination of blood circulating tumor DNA (ctDNA) status and digital pathology score using deep learning in colorectal cancer patients who have undergone radical surgical treatment (including radical surgical treatment after local resection).
Management information
Registered date
| 2025 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | 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=R000067113
