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Multi-institutional collaborative study aiming to elucidate the spatiotemporal molecular profiles for patients with malignant tumor

Multi-institutional collaborative study aiming to elucidate the spatiotemporal molecular profiles for patients with malignant tumor - SCRUM-Japan MONSTAR-SCREEN-3

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000053975
Enrollment
3200
Registered
2024-03-27
Start date
2024-05-01
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

Malignant tumor

Interventions

None listed

Sponsors

National Cancer Center Hospital East
Lead Sponsor
iTMS Co., Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.18 or older when consent is obtained. 2. Pathologically diagnosed with malignant tumor. 3. Obtained written consent from the patient for this study. 4.One of the following applies: Cohort A: Diagnosed with progressive inoperable malignant solid tumor and meets either of the following: (i) Before the first drug therapy. (ii)Preceding drug therapy has ended or is expected to end, and designated targeted therapy is planned as the next treatment. Cohort B: Diagnosed with malignant solid tumor, and curative resection or curative chemotherapy, radiation therapy, or chemoradiotherapy is planned. Cohort C: Diagnosed with hematopoietic malignant tumor and meets either of the following: (i) Before the first drug therapy. (ii)Preceding drug therapy has ended or is expected to end, and the next treatment is planned. 5.ECOG PS is 0 or 1. 6.Expected to survive for 12 weeks or more from the registration date. 7. Residual tissue that can be submitted for this study exists, or it is planned to collect tissue and submit residual tissue. 8.Willing to receive research-based treatment according to the analysis results in this study.

Exclusion criteria

Exclusion criteria: 1.Has a history of allogeneic hematopoietic stem cell transplantation or organ transplantation (Cohorts A and B). 2.Is pregnant. 3.Has a history of or concurrent malignancy other than the target malignancy within 3 years prior to registration. 4.Has a severe comorbidity. (e.g., uncontrolled diabetes, infection, interstitial pneumonia, or pulmonary fibrosis with symptoms) 5.The attending physician determines that registration in this study is inappropriate.

Design outcomes

Primary

MeasureTime frame
i. Molecular profiles such as gene abnormalities, RNA expression profiles, and profiles of biomarkers such as TMB, LOH, MSI, MRD, profiles of genetic abnormalities in germ cell lines, and profiles of intestinal bacterial flora in tumor tissue and ctNA. ii.Image profiles such as pathological image profiles and radiographic image profiles.

Secondary

MeasureTime frame
i. Molecular profiles such as gene abnormalities, RNA expression profiles, and profiles of biomarkers such as TMB, LOH, MSI, profiles of MRD, profiles of genetic abnormalities in germ cell lines, and profiles of intestinal bacterial flora in tumor tissue and ctNA, and their relationship with clinical pathological factors and clinical course. ii. Image profiles such as pathological image profiles and radiographic image profiles, and their relationship with clinical pathological factors and clinical course.

Countries

Japan

Contacts

Public ContactTakao Fujisawa

National Cancer Center Hospital East Department of Head and Neck Medical Oncology

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

Outcome results

None listed

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