SCRUM-Japan MONSTAR-SCREEN-3: Comprehensive tumor microenvironment analysis via multi-omics in a large-scale prospective study.

Background: SCRUM-Japan is a multi-institutional, industry-academia collaborative cancer genome screening project launched in 2015, consisting of LC-SCRUM-Asia for lung cancer and SCRUM-MONSTAR for other malignancies. The project has successfully implemented organ-agnostic liquid biopsy-based precision oncology and molecular residual disease (MRD)-guided therapeutic development, resulting in multiple regulatory approvals of therapeutic agents and diagnostics.

In 2024, MONSTAR-SCREEN-3 was launched to expand the scope of multi-omics analysis beyond advanced solid tumors to include resectable solid tumors and hematologic malignancies, aiming for a comprehensive understanding of tumor microenvironment (TME) dynamics. The project integrates a multi-omics platform, including spatial transcriptomics, ctDNA analysis, and proteomics, to advance personalized medicine and accelerate drug development.

Methods: MONSTAR-SCREEN-3 (UMIN000053975) is a large-scale, multi-institutional prospective study involving 55 centers across Japan, aiming to enroll 3,200 patients across three cohorts: Cohort A: Advanced solid tumors undergoing systemic therapy (n=1,700); Cohort B: Resectable solid tumors receiving perioperative treatment (n=1,100); Cohort C: Hematologic malignancies (n=400).

Our analysis platform combines spatial transcriptomics with circulating tumor DNA/RNA sequencing, bulk tissue whole exome/transcriptome sequencing, plasma proteomics, and microbiome analyses. For resectable cases, standardized longitudinal monitoring with whole genome sequencing-based MRD analysis is implemented, while disease-specific MRD approaches are applied to hematologic malignancies. Following SCRUM-Japan's quality assurance system, standardized monitoring collects regulatory-grade clinical data, including key indicators such as response rate, progression-free survival, and overall survival.

MONSTAR-SCREEN-3 applies standardized protocols for tissue preservation and data acquisition across all centers, ensuring high-quality data. The project leverages the VAPOR CONE supercomputing infrastructure for real-time data integration and AI-driven analysis to identify biomarkers, elucidate resistance mechanisms, and deepen the understanding of tumor-immune interactions. The study aims to establish a framework for next-generation precision oncology.

The latest enrollment status and initial operational results will be reported at the ASCO meeting. MONSTAR-SCREEN-3 is expected to contribute to new therapies, cross-cancer MRD assays, and the resolution of drug lags in hematologic malignancies, driving advancements in personalized cancer treatment.

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Author Details

Mitsuho Imai

Mitsuho Imai

Translational Research Supporting Office, National Cancer Center Hospital East, Kashiwa, Japan

Abstract Details

Meeting

2025 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Track

Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

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Abstract Disclosure