UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030778 |
|---|---|
| Receipt number | 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 01:50:55 |
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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
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
amadakaz@med.showa-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Division of Medical Oncology, Showa University School of Medicine.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035145
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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