A Multicenter Study on Biomarker Development Utilizing AI Multiomics for Patients with Advanced Solid Malignant Tumors

Conditions

Advanced Solid Malignancies

Takao Fujisawa, Yoshiaki Nakamura, Naoya Sakamoto, Riu Yamashita, Takeshi Kuwata et al. (20 authors)

Journal of Clinical Oncology2026-05-27

10.1200/jco.2026.44.16_suppl.3127

FGFR2-IIIc isoform detection reveals prognostic prevalence and a functional link to mesenchymal transition in gastric and gastroesophageal junction cancer.

Hashimoto T, Iida N, Kadowaki S, Makiyama A, Machida N, Takahashi N, Boku S, Kudo T, Oki E, Ohtsubo K, Kawakami T, Okano N, Komatsu Y, Yuki S, Sakamoto N, Kuwata T, Yamashita R, Amisaki M, Shibuki T, Imai M, Fujisawa T, Nakamura Y, Bando H, Shitara K, Yoshino T.

2025-10-30

10.1016/j.esmoop.2025.105851

Clinical significance of the CGRP pathway gene expression in advanced solid tumors: A sub-analysis of MONSTAR-SCREEN-2.

Takao Fujisawa, Naoya Sakamoto, Yoshiaki Nakamura, Riu Yamashita, Takeshi Kuwata et al. (20 authors)

Journal of Clinical Oncology2025-05-28

10.1200/jco.2025.43.16_suppl.2629

Deciphering the prognostic value of <i>FGFR2b/2c</i> isoform expression levels in advanced esophagogastric cancer through whole-transcriptome sequencing.

Tadayoshi Hashimoto, Naoko Iida, Yoshiaki Nakamura, Saori Mishima, Daisuke Kotani et al. (14 authors)

Journal of Clinical Oncology2024-08-10

10.1200/jco.2024.42.23_suppl.53

NEXUS trial: a multicenter phase II clinical study evaluating the efficacy and safety of the perioperative use of encorafenib, binimetinib, and cetuximab in patients with previously untreated surgically resectable BRAF V600E mutant colorectal oligometastases.

Kobayashi S, Bando H, Taketomi A, Takamoto T, Shinozaki E, Shiozawa M, Hara H, Yamazaki K, Komori K, Matsuhashi N, Kato T, Kagawa Y, Yokota M, Oki E, Komine K, Takahashi S, Wakabayashi M, Yoshino T.

2023-08-214 citations

10.1186/s12885-023-11311-5

IMAGENE trial: multicenter, proof-of-concept, phase II study evaluating the efficacy and safety of combination therapy of niraparib with PD-1 inhibitor in solid cancer patients with homologous recombination repair genes mutation.

Kato T, Matsubara N, Shiota M, Eto M, Osawa T, Abe T, Shinohara N, Yasumizu Y, Tanaka N, Oya M, Nishimoto K, Hayashi T, Nakayama M, Kojima T, Namikawa K, Fujisawa T, Okano S, Hida E, Nakamura Y, Bando H, Yoshino T, Nonomura N.

2022-12-091 citations

10.1186/s12885-022-10398-6

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.At least 18 years old when informed consent is obtained. 2.Histopathologically diagnosed as having advanced solid malignancy. 3.No curative treatment is available. 4.Consent has been obtained in writing from the patient regarding participation in this research. 5.Satisfiesb i, ii or iii below. i.Before undergoing first-line systemic therapy. ii.The disease progresses during systemic therapy and the patient is scheduled to undergo designated targeted therapy as the subsequent treatment. iii. Have a specific genetic abnormality 6.Eastern Cooperative Oncology Group performance status is 0 or 1. 7.Can submit a formalin fixed paraffin embedded (FFPE) sample to this research. 8.Does not have any serious coexisting illness (e.g., poorly controlled diabetes mellitus or infectious disease, symptomatic interstitial pneumonia or pulmonary fibrosis, etc.). 9.Is expected to survive for at least 12 weeks from the enrollment date. 10.Willing to undergo investigative treatment according to the results of tissue genome profiling, blood genome profiling, reproductive cell lineage profiling and/or IHC.

Exclusion criteria

Exclusion criteria: 1.Has a history of undergoing allogeneic hematopoietic stem cell transplantation or organ transplantation. 2.Is pregnant. 3.Has a history of another malignant tumor within the three years prior to enrollment. 4.Is judged to be ineligible for enrollment in this research by the study doctor.

Design outcomes

Primary

Measure	Time frame
i. Profiles of gene abnormalities, RNA expression, biomarkers, protein expression, etc. in tumor tissue. ii. Profiles of gene abnormalities, RNA expression, biomarkers, etc. in ctNA. iii. Profile of germline gene abnormalities in blood etc. iv. Gut microbiota profile. v. Plasma protein profile.	—

Secondary

Measure	Time frame
i. Profiles of gene abnormalities, RNA expression, biomarkers, protein expression, etc. in tumor tissue And clinical pathological factors, association with clinical course. ii. Relationship between profile of gene abnormality, RNA expression, biomarker, etc. in ctNA and clinical pathological factors, clinical course. iii. Relationship between Germline Gene Abnormality Profiles in Blood etc and Clinicopathological Factors and Clinical Course. iv. Relationship between gut microbiota profile, clinicopathological factors, and clinical course. v. Associations between plasma protein profiles, clinicopathological factors, and clinical course.	—

Measure

Time frame

i. Profiles of gene abnormalities, RNA expression, biomarkers, protein expression, etc. in tumor tissue And clinical pathological factors, association with clinical course. ii. Relationship between profile of gene abnormality, RNA expression, biomarker, etc. in ctNA and clinical pathological factors, clinical course. iii. Relationship between Germline Gene Abnormality Profiles in Blood etc and Clinicopathological Factors and Clinical Course. iv. Relationship between gut microbiota profile, clinicopathological factors, and clinical course. v. Associations between plasma protein profiles, clinicopathological factors, and clinical course.

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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