UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038703 |
|---|---|
| Receipt number | R000044125 |
| Scientific Title | Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study |
| Date of disclosure of the study information | 2019/11/30 |
| Last modified on | 2023/11/30 11:22:00 |
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Basic information
Public title
Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study
Acronym
Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study
Scientific Title
Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study
Scientific Title:Acronym
Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study
Region
| Japan |
Condition
Condition
Gastroenterological cancer
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To analyze the association between gut microbiome and prognosis in gastroenterological cancer.
Basic objectives2
Others
Basic objectives -Others
To analyze the association between gut microbiome and prognosis in gastroenterological cancer.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To estimate 5-year overall survival in the difference of gut microbiome in gastroenterological cancer.
Key secondary outcomes
To evaluate the association between surgical outcomes and microbiome in the case of gastroenterological cancer
To evaluate the association between the efficacy of preoperative or postoperative treatment and microbiome in the case of gastroenterological cancer
To evaluate the association between surgical outcomes and microbiome in the case of gastroenterological cancer
To evaluate the perioperative complication
To evaluate the tumor infiltrating lymphocytes around the cancer and to investigate the association to microbiota, DNA, RNA or metabolite
To evaluate the association between the postoperative complication and microbiota, DNA, RNA or metabolite
To evaluate the association between complication and risk factor during preoperative treatment
To evaluate the surgical outcomes according to final tumor stages
To evaluate the association between the treatment outcome according to patient background and microbiota, DNA, RNA or metabolite
To evaluate the association among microbiota, DNA, RNA or metabolite in the cancer tissue, oral mucosa or blood tissue.
To evaluate to compare the microbiota, DNA, RNA or metabolite between part of cancer tissue and that of normal tissue.
To evaluate to compare the metabolite such as sulfur metabolite, lipid metabolite, sugar metabolite between part of cancer tissue and that of normal tissue.
To evaluate postoperative endoscopic polypectomy and association to microbiota, DNA, RNA or metabolite in the case of gastroenterological cancer surgery.
To evaluate the recurrence patterns and long-term outcomes and to investigate the association to microbiota, DNA, RNA or metabolite in the case of recurrence after gastroenterological cancer surgery.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
over 18-year-old
confirming gastroenterological cancer pathologically
patients were recieved informed consent
Key exclusion criteria
judgement not to register suitably
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Itaru |
| Middle name | |
| Last name | Endo |
Organization
Yokohama city university school of medicine
Division name
Department of gastroenterological surgery
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
0457872650
t196056a@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Onodera |
Organization
Yokohama city university
Division name
Ethics Committee for Medical Research Involving Human Subjects
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
0457872650
Homepage URL
rinri@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city university
Institute
Department
Personal name
Funding Source
Organization
no funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama city university
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
0457872650
rinri@yokohama-cu.ac.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 30 | 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 | 06 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Compared the difference of gut microbiome and metaborome between tumor site and non-tumor site, follow the prognosis.
Management information
Registered date
| 2019 | Year | 11 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044125
