UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040968 |
|---|---|
| Receipt number | R000046783 |
| Scientific Title | Bacteria In Gut unveiled By singlE-cell geNome analysis |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2023/02/08 14:47:04 |
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Basic information
Public title
Bacteria In Gut unveiled By singlE-cell geNome analysis
Acronym
BIG BEN study
Scientific Title
Bacteria In Gut unveiled By singlE-cell geNome analysis
Scientific Title:Acronym
BIG BEN study
Region
| Japan |
Condition
Condition
Advanced Solid Malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Using single-cell genomics and shotgun metagenomics to build a reference genome sequence database of the gut microbiome in solid tumor patients and use it for detailed profiling
Basic objectives2
Others
Basic objectives -Others
Exploring the association of clinical and genomic information with gut microbiome profiles for the development of new treatments and diagnostics
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Gut microbiome profile by shotgun metagenomics and single cell genome analysis
Key secondary outcomes
Association of clinical information and genomic abnormalities with gut microbiome profiles
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
It's enrolled in MONSTAR-SCREEN (UMIN000036749) and the stool specimen has been collected and there has still the specimen.
Key exclusion criteria
Patients who meet any of the following exclusion criteria 1.) to 3.) are ineligible
1,) Consent for the secondary use of MONSTAR-SCREEN specimens was not obtained.
2,) Consent for the secondary use of MONSTAR-SCREEN specimens was withdrawn.
3,) Your physician decides that you are unsuitable for enrollment in this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | yoshiaki |
| Middle name | |
| Last name | nakamura |
Organization
National Cancer Center Hospital East
Translational Research Management Division, Clinical Research Support Office
Division name
Translational Research Support Section
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
yoshinak@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | kentaro |
| Middle name | |
| Last name | sawada |
Organization
Kushiro Rosai Hospital
Division name
oncology
Zip code
085-8533
Address
13-23 Nakazono, Kushiro, Hokkaido
TEL
0154-22-7191
Homepage URL
kesawada2@gmail.com
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
bitBiome, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chugai Pharmaceutical Co., Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Research Ethics Review Committee
Address
5-1-1 Tsukiji, Chuo, Tokyo
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
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
国立がん研究センター東病院（千葉県）、釧路ろうさい病院（北海道）、関西医科大学附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research design: Observational study
Eligibility: The patients who enrolled in MONSTAR-SCREEN (UMIN000036749)
Management information
Registered date
| 2020 | Year | 07 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046783
| 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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| Registered date | File name |
