UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058035 |
|---|---|
| Receipt number | R000066334 |
| Scientific Title | Clinicopathological features of rectal cancer |
| Date of disclosure of the study information | 2025/06/02 |
| Last modified on | 2025/05/31 19:37:37 |
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Basic information
Public title
Clinicopathological features of rectal cancer
Acronym
Features of rectal cancer
Scientific Title
Clinicopathological features of rectal cancer
Scientific Title:Acronym
Features of rectal cancer
Region
| Japan |
Condition
Condition
colon cancers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will perform statistical analyses using information from endoscopic reports and medical records. This study aims to investigate whether patient characteristics such as age and sex differ depending on the location of colorectal cancer, and to examine the associated pathological features.
Basic objectives2
Others
Basic objectives -Others
We investigated the recurrence rate of rectal cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparative analysis of recurrence rates between rectal and colon cancer
Key secondary outcomes
We compared the clinical features (such as age, sex, and tumor size) and pathological features (such as histological type and tumor budding) between rectal and colon cancer.
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
Inclusion Criteria:
1. Patients who underwent colonoscopy at the Gastroenterology Center of Showa University Northern Yokohama Hospital between April 1, 2021, and December 31, 2022.
2. Patients who did not express a refusal to participate in this study.
3. Patients aged 20 years or older at the time of the examination.
Key exclusion criteria
Patients with other types of colorectal cancer, Lynch syndrome, inflammatory bowel disease, or those who had undergone transanal endoscopic microsurgery were excluded.
Target sample size
3820
Research contact person
Name of lead principal investigator
| 1st name | Yuta |
| Middle name | |
| Last name | Koyama |
Organization
SHOWA Medical University Northern Yokohama Hospital
Division name
Digestive disease center
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama-shi, Kanagawa, Japan
TEL
045-949-7000
sh-iwasaki@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunto |
| Middle name | |
| Last name | Iwasaki |
Organization
SHOWA Medical University Northern Yokohama Hospital
Division name
Digestive disease center
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama-shi, Kanagawa, Japan
TEL
045-949-7000
Homepage URL
sh-iwasaki@med.showa-u.ac.jp
Sponsor or person
Institute
SHOWA Medical University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
SHOWA Medical University Northern Yokohama Hospital, Digestive disease center
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama-shi, Kanagawa, Japan
Tel
045-949-7000
sh-iwasaki@med.showa-u.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
| 2025 | Year | 06 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | 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
Other
Other related information
Study Design:
This is a retrospective study using existing data.
Endoscopic data will be collected from patients who underwent colonoscopy at the Gastroenterology Center of Showa Medical University Northern Yokohama Hospital between April 1, 2001, and December 31, 2022.
The planned study period is from the date of approval by the Ethics Committee for Research Involving Human Subjects at Showa Medical University and subsequent permission from the President of Showa University, until March 31, 2027.
Management information
Registered date
| 2025 | Year | 05 | Month | 31 | Day |
Last modified on
| 2025 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066334
