164TiP - MONSTAR-GLYCO: A multi-institutional prospective study harnessing glycomics and multi-omics on the j-glyconet and SCRUM-MONSTR platform

Background

Recent advances in cancer precision medicine have highlighted the potential of liquid biopsy, particularly circulating tumor DNA (ctDNA) analysis. Simultaneously, glycomics has emerged as a promising field for cancer diagnostics and drug targeting. The Institute for Glyco-core Research (iGCORE) has discovered cancer-associated glycosyltransferases in small extracellular vesicles, suggesting a link between glycomics and cancer progression. Meanwhile, the SCRUM-Japan MONSTAR project has conducted large-scale multi-omics screening studies for advanced cancers and evaluated molecular residual disease (MRD) in resectable cancers using liquid biopsy. MONSTAR-GLYCO, a collaborative study between iGCORE and SCRUM-Japan, seeks to merge glycomics with cancer multi-omics and ctDNA MRD analysis, establishing a comprehensive omics platform.

Trial Design

MONSTAR-GLYCO will enroll 200 patients with resectable solid tumors over a 3-year period, followed by a 2-year follow-upphase. The study will conduct comprehensive multi-omics analysis including whole transcriptome sequencing, whole genome sequencing, and spatial transcriptomics on tissue samples. Blood samples will undergo glycomics, MRD analysis, proteomics, and germline analysis. Additionally, microbiome analysis will be performed on stool and saliva samples. Blood collection is scheduled at eight time points: pre-surgery and post-surgery at 1, 3, 6, 9, 12, 18, and 24 months. Additional samples will be collected pre-treatment for neoadjuvant therapy cases and at recurrence. Glycomics will focus on glycosyltransferases (e.g., GnT-V, ST6GAL1) and glycan structure analysis. The primary objective is to evaluate the association between integrated MRD and glycomics with cancer recurrence. Secondary objectives include exploring correlations between glycomics and other multi-omics data, identifying prognostic factors and potential therapeutic targets among glycan molecules, and developing a novel prognostic model integrating multi-omics data. This study aims to establish a new omics platform based on glycan information.

Editorial acknowledgement

Clinical trial identification

Legal entity responsible for the study

The authors.

Funding

This work was supported by the Assisted Joint Research Program (Exploration Type) of the J-GlycoNet cooperative network, which is accredited by the Minister of Education, Culture, Sports, Science and Technology, MEXT, Japan, as a Joint Usage/Research Center.

Disclosure

M. Imai-Sumida: Financial Interests, Personal, Invited Speaker: Guardant Health, Inc., Caris Life Sciences, Sumitomo Corp. T. Fujisawa: Financial Interests, Personal, Invited Speaker: Amelieff Co Ltd. Y. Nakamura: Financial Interests, Personal, Invited Speaker: Chugai, Merck Biopharma, Guardant Health Pte Ltd., MSD K.K, Eisai, Zeria Pharmaceutical, Miyarisan Pharmaceutical, CareNet, Inc., Hisamitsu Pharmaceutical, Taiho Pharmaceutical, Daiichi Sankyo Co., Ltd., Becton Dickinson, Guardant Health Japan Corp.; Financial Interests, Personal, Advisory Board: Natera, Inc., Roche Ltd., Seagen, Inc., Premo Partners, Inc., Daiichi Sankyo Co., Ltd., Takeda, Exact Sciences, Gilead Sciences, Guardant Health Pte Ltd.; Financial Interests, Institutional, Funding: Taiho, Chugai, Guardant Health, Genomedia, Daiichi Sankyo, Roche Diagnostics, Guardant Health Amea, Inc., Tempus; Financial Interests, Institutional, Invited Speaker: Seagen. H. Bando: Financial Interests, Institutional, Research Grant: Ono Pharmaceutical; Other, Personal, Other, Lecture fee: Ono Pharmaceutical, Taiho Pharmaceutical, Eli Lilly Japan. A. Makiyama: Financial Interests, Personal, Invited Speaker: Eli Lilly, Taiho, Ono, Daiichi Sankyo, Bristol Myers Squibb. N. Matsuhashi: Financial Interests, Personal, Invited Speaker: Abbott, AMCO Inc., Asahi Kasei Pharma, AstraZeneca, Bayer Yakuhin, Bristol Myers Squibb, Chugai Pharm, Covidien Japan, Daiichi Sankyo, EA Pharma, Eisai, Eli Lilly Japan, Gunze Medical Limited, Johnson & Johnson, Kaken Pharma, Kyowa Kirin, MC Medical, Merck Biopharma Japan, Miyarisan Pharma, MSD, Ono Pharma, Stryker, Taiho Pharm, Takeda Pharm, Terumo, Tsumura, Viatris, Yakult Honsha; Financial Interests, Institutional, Research Grant: Asahi Kasei Pharma, Chugai Pharma, Covidien Japan, Daiichi Sankyo, Eisai, Johnson & Johnson, Kaken Pharm, Kyowa Kirin, Nippon Kayaku, Taiho Pharm, Toray Medical; Financial Interests, Institutional, Funding: EP-CRSU, EPS Corporation, MSD, Ono Pharma, Shift Zero K.K. T. Yoshino: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd., Merck Biopharma Co., Ltd., Bayer Yakuhin, Ltd., Ono Pharmaceutical Co., Ltd., MSD K.K., Takeda Pharmaceutical Co., Ltd.; Financial Interests, Personal, Other, Consultancy: Sumitomo Corp.; Financial Interests, Institutional, Research Grant: Ono Pharmaceutical Co., Ltd., Sanofi K.K., MSD K.K., Taiho Pharmaceutical Co., Ltd., Molecular Health GmbH, Amgen K.K., Pfizer Japan Inc., Genomedia Inc., Sysmex Corp., Daiichi Sankyo Co., Ltd., Chugai Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Eisai Co., Ltd., Roche Diagnostics K.K., Falco Biosystems Ltd., Merus N.V., Bristol Myers Squibb K.K., Medical & Biological Laboratories Co., Ltd., Takeda Pharmaceutical Co., Ltd. All other authors have declared no conflicts of interest.