UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032733 |
|---|---|
| Receipt number | R000037230 |
| Scientific Title | Clinicopathological differences between right and left-sided T1 colorectal cancer |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2020/12/23 14:53:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinicopathological differences between right and left-sided T1 colorectal cancer
Acronym
Clinicopathological differences between right and left-sided T1 colorectal cancer
Scientific Title
Clinicopathological differences between right and left-sided T1 colorectal cancer
Scientific Title:Acronym
Clinicopathological differences between right and left-sided T1 colorectal cancer
Region
| Japan |
Condition
Condition
early colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to compare the clinicopathological features of right- and left-sided T1 colorectal cancers.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinicopathological features included patient age, sex, initial treatment, tumor size, morphology, invasion depth, histological grade, lymphatic invasion, vascular invasion, tumor budding, and lymph node metastasis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
T1 colorectal cancers undergoing surgical resection with lymph node dissection
Key exclusion criteria
Cases of familial adenomatous polyposis, Lynch syndrome, ulcerative colitis, synchronous invasive carcinoma
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Mochizuki |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL
0459497000
k.mochizuki@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Mochizuki |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
224-8503
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
TEL
0459497000
Homepage URL
k.mochizuki@med.showa-u.ac.jp
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Institutional Review Board in Showa University Northern Yokohama Hospital,
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama, Japan
Tel
0459497000
k.mochizuki@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
昭和大学横浜市北部病院 消化器センター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00384-020-03668-x
Number of participants that the trial has enrolled
1142
Results
Left-sided T1 colorectal cancer(CRC) showed significantly higher rates of lymph node metastasis(LNM; left-sided 12.0% vs. right-sided 5.4%, P < 0.05) and lymphatic invasion (left-sided 32.7% vs. right-sided 23.2%, P < 0.05). Especially, the sigmoid colon and rectum showed higher rates of LNM than other locations. Patients with left-sided T1 CRC were younger than those with right-sided T1 CRC , as well as significantly lower rates of poorly differentiated carcinoma/mucinous carcinoma than right-sided T1 CRC.
Results date posted
| 2020 | Year | 12 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 06 | Month | 16 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects were 1,142 cases with T1 CRCs undergoing surgical resection with lymph node dissection at Showa University Northern Yokohama Hospital. Of these, 366 cases were right-sided (cecum to transverse colon), and 776 cases were left-sided (descending colon to rectum). Analyzed clinicopathological features included patient age, sex, initial treatment, tumor size, morphology, invasion depth, histological grade, lymphatic invasion, vascular invasion, tumor budding, and lymph node metastasis.
Management information
Registered date
| 2018 | Year | 05 | Month | 27 | Day |
Last modified on
| 2020 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037230
