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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000038569 |
Receipt No. | 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 | 2019/11/13 |
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 |
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Condition | ||||
Condition | Colon cancer | |||
Classification by specialty |
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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 | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |||||||
yusakuwatanabe@med.kawasaki-m.ac.jp |
Sponsor | |
Institute | Kawasaki Medical School |
Institute | |
Department |
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 |
kenkyuhou@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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Other | |
Other related information | none |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043863 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |