UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060793 |
|---|---|
| Receipt number | R000068986 |
| Scientific Title | Multicenter Collaborative Study on Biomarker Analysis Using Circulating Tumor DNA in Resectable Solid Tumors |
| Date of disclosure of the study information | 2026/03/02 |
| Last modified on | 2026/03/02 09:20:13 |
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Basic information
Public title
Multicenter Collaborative Study on Biomarker Analysis Using Circulating Tumor DNA in Resectable Solid Tumors
Acronym
MONSTAR-3.5:MONSTAR-MUGEN
Scientific Title
Multicenter Collaborative Study on Biomarker Analysis Using Circulating Tumor DNA in Resectable Solid Tumors
Scientific Title:Acronym
MONSTAR-3.5:MONSTAR-MUGEN
Region
| Japan |
Condition
Condition
Clinical stage I-IV resectable solid tumors planned to be treated with definitive therapy
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Endocrinology and Metabolism | Neurology |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology | Ophthalmology | Dermatology |
| Oto-rhino-laryngology | Urology | Oral surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to identify biomarkers reflecting the molecular biological nature of resectable solid tumors by performing comprehensive molecular profiling of blood and tumor tissue specimens from patients undergoing curative-intent treatment, and integrating these data with clinical information.
Basic objectives2
Others
Basic objectives -Others
Correlation between molecular profiles, including genetic alterations in tumor tissue and MRD, and their relationship with clinicopathological factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between molecular profiles, including genetic alterations in tumor tissue and MRD, and relapse and prognosis
Key secondary outcomes
Correlation between molecular profiles, including genetic alterations in tumor tissue and MRD, and their relationship with clinico pathological 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
Patients who meet all eligibility criteria and none of the exclusion criteria will be enrolled in this study.
1)18 years-old <=
2)Diagnosed with a resectable solid tumor of clinical stage I-IV.
3)Planned to undergo curative-intent treatment, including curative surgical resection or definitive chemotherapy/chemoradiotherapy.*1
4)Availability of tumor tissue specimens for pathological evaluation.*2
5)ECOG Performance Status (PS) of 0 or 1.
6)Written informed consent.
*1 Patients scheduled for curative resection are eligible even if they undergo preoperative chemoradiotherapy.
*2 A tissue biopsy prior to treatment initiation is preferred; however, surgical specimens are acceptable in cases undergoing surgery.
Key exclusion criteria
1)Active multiple primary cancers
2)Pregnant
3)History of other malignancies within 3 years prior to enrollment
4)Severe comorbid diseases (e.g., poorly controlled diabetes, infections, symptomatic interstitial pneumonia or pulmonary fibrosis)
5)Other reasons deemed inappropriate for this study by the principal investigator.
Target sample size
4000
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 of Drug Development Promotion
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 of Drug Development Promotion
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
Myriad Genetics,Inc/iTMS,Inc/National Cancer Center Hospital East
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
iTMS,Inc
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・仙台市医療センター 仙台オープン病院・大阪医療センター・高知大学医学部附属病院・産業医科大学病院・新潟大学大学院医歯学総合研究科・兵庫医科大学・東邦大学医療センター佐倉病院・岡山大学病院・千葉大学大学院医学研究院・埼玉医科大学国際医療センター・関西医科大学附属病院・北里大学・国立がん研究センター中央病院・大阪急性期・総合医療センター・藤田医科大学病院・弘前大学医学部附属病院・東京慈恵会医科大学・筑波大学附属病院・関西労災病院・医療法人薫風会佐野病院・大阪大学医学部附属病院・横浜市立大学附属病院・箕面市立病院・名古屋市立大学・九州中央病院・島根県立中央病院・岐阜大学医学部附属病院・東京都立駒込病院・熊本大学病院 ・金沢大学附属病院・浜松医科大学医学部附属病院・大阪医科薬科大学病院・地方独立行政法人市立東大阪医療センター・神奈川県立がんセンター・埼玉県立がんセンター・九州大学病院・公益財団法人がん研究会有明病院・九州がんセンター・帝京大学ちば総合医療センター・りんくう総合医療センター・広島大学病院・東北大学病院・聖マリアンナ医科大学病院・大阪国際メディカル&サイエンスセンター大阪けいさつ病院・大阪国際がんセンター・横浜市立大学附属市民総合医療センター・刈谷豊田総合病院 ・京都桂病院・岐阜市民病院・飯塚病院・公益財団法人大原記念倉敷中央医療機構 倉敷中央病院・岐阜県総合医療センター・姫路赤十字病院・手稲渓仁会病院・愛知県がんセンター・済生会福岡総合病院・慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | 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 | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068986
