UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038569 |
|---|---|
| Receipt number | R000043863 |
| Scientific Title | Analysis of intestinal bacterial flora in adjuvant chemotherapy combined with oxaliplatin for stage III curatively resected colorectal cancer |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2020/11/13 18:42:56 |
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Basic information
Public title
Analysis of intestinal bacterial flora in adjuvant chemotherapy combined with oxaliplatin for stage III curatively resected colorectal cancer
Acronym
Analysis of intestinal bacterial flora in adjuvant chemotherapy combined with oxaliplatin for stage III curatively resected colorectal cancer
Scientific Title
Analysis of intestinal bacterial flora in adjuvant chemotherapy combined with oxaliplatin for stage III curatively resected colorectal cancer
Scientific Title:Acronym
Analysis of intestinal bacterial flora in adjuvant chemotherapy combined with oxaliplatin for stage III curatively resected colorectal cancer
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study analyzes the gut microbiota in patients who received adjuvant chemotherapy with oxaliplatin for stage III curatively resected colorectal cancer. The main objective is to examine how dysbiosis from adjuvant chemotherapy affects the patient's quality of life (QOL) and adverse event profile.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between changes in gut microbiota and side effects of chemotherapy.
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
A case of colon cancer histopathologically diagnosed as Stage III
Key exclusion criteria
Patients under 20 years old
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Tanaka |
Organization
Kawasaki Medical School
Division name
Digestive Surgery
Zip code
701-0192
Address
577 Matsusima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
yusakuwatanabe@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Yusaku |
| Middle name | |
| Last name | Watanabe |
Organization
Kawasaki Medical School
Division name
Digestive Surgery
Zip code
701-0192
Address
577 Matsusima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
Homepage URL
tanakahr@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Self sustaining
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
Kawasaki Medical School
Address
577 Matsusima, Kurashiki city, Okayama, Japan
Tel
086-462-1111
kmsrec@med.kawasaki-m.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 | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 11 | Month | 13 | Day |
Last modified on
| 2020 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043863
