UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The analysis of the microbiota as biomarkers of response to anticancer drugs in metastatic solid cancers
Title of the study (Brief title)	The analysis of Microbiota in the efficacy of anticancer drugs
Region	Japan

Condition
Condition	Advanced or recurrent cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze the effect of the microbiota in anticancer drugs efficacy and toxicity
Basic objectives2	Others
Basic objectives -Others	The effect of intratumor bacteria on anticancer drugs efficacy and toxicity
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To identify oral and gut microbiota signatures for responders and nonresponders to anticancer drugs.
Key secondary outcomes	Progression-free survival. Overall survival Oral and gut microbiota signatures for patients with early tumor shrinkage Oral and gut microbiota signatures for adverse event To identify species of intratumor bacteria 12-month PFS rate in cancer patients with or without intratumor bacteria Relationship intratumor bacteria and cancer tissue expression of immune-related proteins Detection of bacterial 16S rRNA in human blood Plasma levels of cytokines or chemokines associated with microbiota signatures Immune cell subsets in peripheral blood analysis by flow cytometry

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Age of more than 20 years old. (2) Written informed consent.
Key exclusion criteria	(1)Serological positive for HBs antigen, HCV antibody, or HIV antibody (2) An inappropriate case judged by doctor in charge.
Target sample size	60

Research contact person
Name of lead principal investigator	Kazuyuki Hamada
Organization	Showa University
Division name	Department of Internal Medicine, Division of Medical Oncology
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo 142-8666, JAPAN
TEL	03-3784-8402
Email	hamadakaz@med.showa-u.ac.jp

Public contact
Name of contact person	Kazuyuki Hamada
Organization	Showa University
Division name	Department of Internal Medicine, Division of Medical Oncology
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo 142-8666, JAPAN
TEL	03-3784-8402
Homepage URL
Email	amadakaz@med.showa-u.ac.jp

Sponsor
Institute	Department of Internal Medicine, Division of Medical Oncology, Showa University School of Medicine.
Institute
Department

Funding Source
Organization	Department of Internal Medicine, Division of Medical Oncology, Showa University School of Medicine.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Clinical Immune Oncology, Clinial Research Institute of Clinical Pharmacology and Therapeutics, Showa University.
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	昭和大学病院（東京都)

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 12 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 26 Day
Anticipated trial start date	2018 Year 01 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	An observational study of solid cancer patients. To identify oral and gut microbiota signatures for responders and nonresponders to anticancer drugs. Progression-free survival. Overall survival Oral and gut microbiota signatures for patients with early tumor shrinkage Oral and gut microbiota signatures for adverse event To identify species of intratumor bacteria 12-month PFS rate in cancer patients with or without intratumor bacteria Relationship intratumor bacteria and cancer tissue expression of immune-related proteins Detection of bacterial 16S rRNA in human blood Plasma levels of cytokines or chemokines associated with microbiota signatures Immune cell subsets in peripheral blood analysis by flow cytometry

Management information
Registered date	2018 Year 01 Month 12 Day
Last modified on	2018 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035145