UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060553 |
|---|---|
| Receipt number | R000069265 |
| Scientific Title | A Multicenter Collaborative Study on Molecular Profiling and Biomarker Analysis for the Development of Personalized Perioperative Treatment in Resectable Solid Tumors |
| Date of disclosure of the study information | 2026/02/02 |
| Last modified on | 2026/02/02 15:32:18 |
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Basic information
Public title
A Multicenter Collaborative Study on Molecular Profiling and Biomarker Analysis for the Development of Personalized Perioperative Treatment in Resectable Solid Tumors
Acronym
MONSTAR-3.5: MONSTAR-KRONOS
Scientific Title
A Multicenter Collaborative Study on Molecular Profiling and Biomarker Analysis for the Development of Personalized Perioperative Treatment in Resectable Solid Tumors
Scientific Title:Acronym
MONSTAR-3.5: MONSTAR-KRONOS
Region
| Japan |
Condition
Condition
Resectable solid tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Breast surgery | Obstetrics and Gynecology |
| Urology | Radiology | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to perform molecular profiling of blood and tissue samples in patients with resectable solid tumors undergoing curative treatment, and to integrate these data with clinical information to identify biomarkers that reflect the molecular biological characteristics.
Basic objectives2
Others
Basic objectives -Others
The study will investigate the relationships among molecular profiles in blood and tumor tissue such as genomic alterations, RNA expression, and molecular residual disease (MRD), and their associations with therapeutic efficacy, treatment course, imaging findings, pathological findings, and other clinicopathological factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between molecular profiles in blood and tumor tissue such as genomic alterations, RNA expression, and molecular residual disease (MRD), and recurrence status or clinical outcomes.
Key secondary outcomes
The relationships among molecular profiles in blood and tumor tissue such as genomic alterations, RNA expression, and molecular residual disease (MRD), and their associations with therapeutic efficacy, treatment course, imaging findings, pathological findings, and other clinicopathological factors.
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
1. The patient is 18 years of age or older at the time of obtaining consent.
2. The patient has been diagnosed with one of the following resectable malignant solid tumors, at clinical stage I-IV
Gastric cancer, pancreatic cancer, liver cancer, breast cancer, ovarian cancer, bladder cancer, or endometrial cancer
3. The patient is scheduled to undergo curative resection or curative chemotherapy and or chemoradiotherapy. *1
4. The patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
5. Written informed consent for participation in this study has been obtained from the patient.
*1 Patients who are scheduled for curative resection are eligible even if they undergo preoperative chemoradiotherapy or chemotherapy.
Key exclusion criteria
1. The patient has double cancer.*1
2. The patient is pregnant.
3. The patient has a history of, or concurrent, other malignancies within 3 years prior to enrollment.
4. The patient has serious comorbidities (e.g., uncontrolled diabetes or infections, symptomatic interstitial pneumonia or pulmonary fibrosis, etc.).
5. The patient is deemed by the principal investigator to be otherwise inappropriate for participation in this study.
*1: Includes synchronous or multiple cancers, as well as metachronous cancers with a disease-free interval of less than 3 years.
However, the following histories are not considered active double/multiple cancers, even if the disease-free interval is less than 3 years, provided they have been completely resected and correspond to the pathological stages listed below:
Gastric cancer (adenocarcinoma, common type): Stage 0-I
Colon cancer (adenocarcinoma): Stage 0-I
Rectal cancer (adenocarcinoma): Stage 0-I
Esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basaloid carcinoma): Stage 0
Breast cancer (DCIS, LCIS): Stage 0
Breast cancer (invasive ductal carcinoma, invasive lobular carcinoma, Paget disease): Stage 0-IIA
Endometrial cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): Stage I
Prostate cancer (adenocarcinoma): Stage I-II
Cervical cancer (squamous cell carcinoma): Stage 0
Thyroid cancer (papillary carcinoma, follicular carcinoma): Stage I-III
Renal cancer (clear cell carcinoma, chromophobe carcinoma): Stage I
Other lesions equivalent to carcinoma in situ of mucosal origin
Staging is based on the UICC-TNM Classification, 8th Edition.
Target sample size
1400
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
Institute
Department
Personal name
Funding Source
Organization
iTMS Co., Ltd.
Tempus AI, Inc.
National Cancer Center
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
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
国立がん研究センター東病院（千葉県）、国立がん研究センター中央病院（東京都）、岐阜大学医学部附属病院（岐阜県）、岡山大学病院（岡山県）、関西医科大学附属病院（大阪府）、大阪大学医学部附属病院（大阪府）、神奈川県立がんセンター（神奈川県）、独立行政法人国立病院機構大阪医療センター（大阪府）、金沢大学附属病院（石川県）、名古屋市立大学（愛知県）、九州がんセンター（福岡県）、近畿大学医学部（大阪府）、埼玉県立がんセンター（埼玉県）、聖マリアンナ医科大学病院（神奈川県）、東北大学病院（宮城県）、筑波大学附属病院（茨城県）、関西労災病院（兵庫県）、九州大学病院（福岡県）、高知大学医学部（高知県）、独立行政法人国立病院機構四国がんセンター（愛媛県）、広島大学病院（広島県）、埼玉医科大学国際医療センター（埼玉県）、愛知県がんセンター（愛知県）、静岡県立静岡がんセンター（静岡県）、大阪国際がんセンター（大阪府）、福島県立医科大学（福島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter, exploratory, prospective, non-interventional study.
In this study, blood samples will primarily be collected in addition to blood draws performed for routine clinical purposes. However, blood collection solely for research purposes is also permitted. Research specimens will also be prepared from surplus samples obtained during biopsy and surgery.
These specimens will be analyzed, and the results will be integrated with clinical data collected via an Electronic Data Capture (EDC) system, including imaging profiles such as pathological and radiological image profiles.
Management information
Registered date
| 2026 | Year | 02 | Month | 02 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069265
