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Multicenter Collaborative Study on Biomarker Analysis Using Circulating Tumor DNA in Resectable Solid Tumors

Multicenter Collaborative Study on Biomarker Analysis Using Circulating Tumor DNA in Resectable Solid Tumors - MONSTAR-3.5:MONSTAR-MUGEN

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000060793
Enrollment
4000
Registered
2026-03-02
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical stage I-IV resectable solid tumors planned to be treated with definitive therapy

Interventions

None listed

Sponsors

National Cancer Center Hospital East
Lead Sponsor
iTMS,Inc
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Association between molecular profiles, including genetic alterations in tumor tissue and MRD, and relapse and prognosis

Secondary

MeasureTime frame
Correlation between molecular profiles, including genetic alterations in tumor tissue and MRD, and their relationship with clinico pathological factors.

Countries

Japan

Contacts

Public ContactTadayoshi Hashimoto

National Cancer Center Hospital East Department of Drug Development Promotion

tadhashi@east.ncc.go.jp04-7133-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026