UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049816 |
|---|---|
| Receipt number | R000056740 |
| Scientific Title | Prospective observational study to examine the effect of chemotherapy on the microbiota of pancreatic cancer. |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/12/19 02:55:36 |
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Basic information
Public title
Prospective observational study to examine the effect of chemotherapy on the microbiota of pancreatic cancer.
Acronym
Prospective observational study to examine the effect of chemotherapy on the microbiota of pancreatic cancer.
Scientific Title
Prospective observational study to examine the effect of chemotherapy on the microbiota of pancreatic cancer.
Scientific Title:Acronym
Prospective observational study to examine the effect of chemotherapy on the microbiota of pancreatic cancer.
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This is a prospective observational study to examine the effect of chemotherapy on the microbiota of pancreatic cancer by 16SrRNA meta-analysis. We will also examine specimens obtained from resected pancreatic cancer or biopsied tissues to clarify the relationship between the gut microbiota and the tumor microenvironment.
Basic objectives2
Others
Basic objectives -Others
Biological exploration
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of chemotherapy on the gut microbiota and tumor microenvironment of pancreatic cancer
Key secondary outcomes
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. Patients with pancreatic cancer diagnosed with a suspicious of adenocarcinoma or adenocarcinoma on preoperative histopathological examination
2. Patients with pancreatic cancer scheduled for chemotherapy
Key exclusion criteria
1.Patients who do not have written consent
2.Patients already taking probiotics at the time of enrollment
3.Patients requiring continuous administration of steroids and immunosuppressant drugs
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Kawai |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
6418510
Address
811-1, Kimiidera, Wakayama, Wakayama Prefecture, 641-8510, Japan
TEL
0734410613
kawai@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yoshimura |
Organization
Wakayama Medical University
Division name
Second Department of Surgery
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama, Wakayama Prefecture, 641-8510, Japan
TEL
0734410613
Homepage URL
t-yoshi@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent ethics committee of Wakayama Medical University
Address
811-1, Kimiidera, Wakayama, Wakayama Prefecture, 641-8510, Japan
Tel
0734472300
wa-rinri@wakayama-med.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
| 2023 | Year | 01 | 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
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2022 | Year | 12 | Month | 19 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056740
