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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030778
Receipt No. R000035145
Scientific Title The analysis of the microbiota as biomarkers of response to anticancer drugs in metastatic solid cancers
Date of disclosure of the study information 2018/01/12
Last modified on 2018/01/12

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Basic information
Public title The analysis of the microbiota as biomarkers of response to anticancer drugs in metastatic solid cancers
Acronym The analysis of Microbiota in the efficacy of anticancer drugs
Scientific Title The analysis of the microbiota as biomarkers of response to anticancer drugs in metastatic solid cancers
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuyuki Hamada
Organization Showa University
Division name Department of Internal Medicine, Division of Medical Oncology
Zip code
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
1st name
Middle name
Last name Kazuyuki Hamada
Organization Showa University
Division name Department of Internal Medicine, Division of Medical Oncology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 26 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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