UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039401 |
|---|---|
| Receipt number | R000044924 |
| Scientific Title | Prospective Observational Study Identifying Intestinal Flora Associated with Inflammatory Carcinogenesis |
| Date of disclosure of the study information | 2020/02/05 |
| Last modified on | 2023/08/11 11:28:50 |
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Basic information
Public title
Prospective Observational Study Identifying Intestinal Flora Associated with Inflammatory Carcinogenesis
Acronym
Prospective Observational Study Identifying Intestinal Flora Associated with Inflammatory Carcinogenesis
Scientific Title
Prospective Observational Study Identifying Intestinal Flora Associated with Inflammatory Carcinogenesis
Scientific Title:Acronym
Prospective Observational Study Identifying Intestinal Flora Associated with Inflammatory Carcinogenesis
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify the specific bacterial flora that colonizes the colonic mucosal surface and the surface of cancer tissue by removing the mucus layer from surgically removed specimens of human inflammatory carcinogenesis cases by 16S rRNA gene analysis.
Basic objectives2
Others
Basic objectives -Others
To identify the association between colorectal cancer and specific bacterial flora
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in bacterial flora composition between colorectal cancer with ulcerative colitis and sporadic colorectal 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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cT2-T4 colorectal cancer
Key exclusion criteria
cTis or cT1 colorectal cancer
cT2-T4 small colorectal cancer
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Uyama |
Organization
Fujita Health University
Division name
Gastrointestinal Surgery
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9254
yosuketajimajpn@gmail.com
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Tajima |
Organization
Fujita Health University
Division name
Gastrointestinal Surgery
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562-93-9254
Homepage URL
yosuketajimajpn@gmail.com
Sponsor or person
Institute
Fujita Hearth University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2020 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9616824/pdf/41598_2022_Article_21928.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9616824/pdf/41598_2022_Article_21928.pdf
Number of participants that the trial has enrolled
18
Results
Sutterella and Enterobacteriaceae were enriched in the mucus covering the mucosa relative to the mucosa. Rikenellaceae was enriched in the mucus covering cancer tissues compared with those same cancer tissues. Ruminococcaceae, Enterobacteriaceae, and Erysipelotrichaceae were enriched in the mucus covering the mucosa compared with the mucus covering cancers. Fusobacterium was enriched in the mucus covering cancers compared with the mucus covering the mucosa.
Results date posted
| 2023 | Year | 08 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 18 CRC patients who underwent primary tumor resection between February 2020 and January 2021 at the Fujita University Hospital were enrolled. Patients who received preoperative chemotherapy or radiotherapy were excluded. Patients with familial adenomatous polyposis or inflammatory bowel disease were excluded. None of the patients had received antibiotics within a month before surgery.
Participant flow
A total of 18 CRC patients who underwent primary tumor resection between February 2020 and January 2021 at the Fujita University Hospital were enrolled. Patients who received preoperative chemotherapy or radiotherapy were excluded. Patients with familial adenomatous polyposis or inflammatory bowel disease were excluded. None of the patients had received antibiotics within a month before surgery.
Adverse events
None
Outcome measures
The mucus depth was compared between before and after washing by Wilcoxon signed-rank test to evaluate whether mucus was removed by high-pressure washing with sterile saline. Comparisons of the relative abundances of taxa between mucus and washed tissue samples were also assessed by the Wilcoxon signed-rank test. Only phyla or genera with a median relative abundance >0.01 in at least one group were selected for this analysis. The Benjamini-Hochberg method for controlling the false-discovery rate was used to account for multiple comparisons. The Shannon diversity index was used to evaluate alpha diversity and was compared between mucus and washed tissue samples once again by the Wilcoxon signed-rank test. PERMANOVA comparisons of beta diversity were run using the R package vegan [34]. Statistical analyses were performed using IBM SPSS Statistics 27 (IBM Japan Inc., Tokyo, Japan). P values less than 0.05 were considered statistically significant.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in paticular
Management information
Registered date
| 2020 | Year | 02 | Month | 05 | Day |
Last modified on
| 2023 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044924
