Multicenter Study to Profile and Monitor Cancer-related Genomic Alterations in Circulating Tumor DNA and the Gut Microbiome in Advanced Solid Malignancies

Conditions

Advanced Solid Malignancies

Mishima S, Nakamura Y, Tukachinsky H, Taniguchi H, Kadowaki S, Kato K, Oki E, Satoh T, Aoki D, Yamazaki K, Esaki T, Ueno M, Nishina T, Sunakawa Y, Denda T, Bando H, Kuramoto N, Horasawa S, Abutani H, Lee JK, Madison RW, Oxnard GR, Yoshino T.

2023-08-1011 citations

10.1016/j.jlb.2023.100003

Landscape of genomic alterations of circulating tumor DNA in advanced genitourinary cancer patients: SCRUM-Japan MONSTAR SCREEN Project.

Nobuaki Matsubara, Taigo Kato, Takao Fujisawa, Masaki Shiota, Masatoshi Eto et al. (18 authors)

Journal of Clinical Oncology2021-02-203 citations

10.1200/jco.2021.39.6_suppl.152

Characteristics of genomic alterations in circulating tumor DNA (ctDNA) in patients (Pts) with advanced gastrointestinal (GI) cancers in nationwide large-scale ctDNA screening:SCRUM-Japan Monstar-Screen.

Yoshiaki Nakamura, Takao Fujisawa, Shigenori Kadowaki, Naoki Takahashi, Masahiro Goto et al. (18 authors)

Journal of Clinical Oncology2021-01-204 citations

10.1200/jco.2021.39.3_suppl.106

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Is at least 16 years of age at the time of consent. 2. Has a histopathologically confirmed solid malignancy. 3. Has unresectable lesions. 4. Has undergone or is scheduled to undergo a comprehensive genomic profile that uses tumor tissue. 5. Has personally given consent in writing to participate in this study. 6. Satisfies either i or ii below: i. Has not undergone chemotherapy. ii. Was found to have progressed in diagnostic imaging performed while receiving chemotherapy or assessed by the investigator of likely having clinical progressive disease and has not yet begun the subsequent chemotherapy. 7. Has an Eastern Cooperative Oncology Group performance status of 0 or 1. 8. Results of latest laboratory tests performed within 21 days of enrollment satisfy all of the following . 9. Has no serious comorbidities. 10. Has a remaining life expectancy of at least 12 weeks after the day of enrollment. 11. Intends to receive study treatment based on the results of genomic alteration analysis. 12. Meets the description of one of Cohorts A to D below: Cohort A: Patients with certain solid malignancies who have not undergone chemotherapy Patients who have not yet undergone initial chemotherapy for an advanced solid malignancy specified. Cohort B: Patients with certain genomic alterations Patients found to have a genomic alteration specified in Reference Material in comprehensive genomic profile, the GOZILA Study, or FoundationOne Liquid of the present study and are scheduled to undergo chemotherapy as their subsequent chemotherapy. Cohort C: Patients scheduled to undergo treatment with an immune checkpoint inhibitor Patients whose next scheduled treatment is an immune checkpoint inhibitor. Cohort D: Patients scheduled to undergo treatment with certain molecular targeted drugs Patients whose next scheduled treatment is chemotherapy with a molecular targeted drug able to cause clonal evolution.

Exclusion criteria

Exclusion criteria: 1. Has previously undergone an autologous stem cell transplant or organ transplant. 2. Has a history of other malignancies. 3. If found by the investigator to be unsuited to participate in the study.

Design outcomes

Primary

Measure	Time frame
Profiles of ctDNA cancer-related genomic alterations and the gut microbiome	—

Countries

Japan

Contacts

Public ContactYoshiaki Nakamura

National Cancer Center Hospital East Department of Gastroenterology and Gastrointestinal Oncology

yoshinak@east.ncc.go.jp04-7133-111

Outcome results