UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048369 |
|---|---|
| Receipt number | R000055124 |
| Scientific Title | Study of appropriate CRM using preoperative MRI evaluation for cecal cancer and ascending colon cancer |
| Date of disclosure of the study information | 2022/07/13 |
| Last modified on | 2022/07/13 18:37:02 |
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Basic information
Public title
Study of appropriate CRM using preoperative MRI evaluation for cecal cancer and ascending colon cancer
Acronym
Study of appropriate CRM using preoperative MRI evaluation for cecal cancer and ascending colon cancer
Scientific Title
Study of appropriate CRM using preoperative MRI evaluation for cecal cancer and ascending colon cancer
Scientific Title:Acronym
Study of appropriate CRM using preoperative MRI evaluation for cecal cancer and ascending colon cancer
Region
| Japan |
Condition
Condition
Colon cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between estimated CRM using MRI in colon cancer and pathological CRM in a novel specimen preparation method for colon cancer. Also, to prove that CRM assurance in colon cancer is useful for local control as well as remote control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Match rate between estimated CRM and pathological CRM
Key secondary outcomes
Recurrence rate 3 years after surgery(peritoneal dissemination, local recurrence)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have undergone colonoscopy and have been diagnosed with colorectal cancer or ascending colon cancer by endoscopy and fluoroscopy or CT or MRI.
2. Patients whose preoperative T factor can be diagnosed as deeper than T2 by endoscopy or CT.
3. Patients who can undergo R0 resection (curative resection) by laparotomy or laparoscopic surgery.
4. Patients aged 18 years or older at the time of consent acquisition.
5. Patients who have received sufficient explanation in participating in this study, and who have obtained sufficient understanding and voluntary written consent of the patient.
Key exclusion criteria
1. Patients with Stage IV with distant metastasis and peritoneal dissemination
2. Patients with double cancer
3. Patients with multiple cancers
4. Other patients who the principal investigator deems inappropriate for research
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eguchi |
| Middle name | |
| Last name | Susumu |
Organization
Nagasaki university
Division name
Department of Surgery
Zip code
8528102
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL
0958197317
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Adachi |
| Middle name | |
| Last name | Toshiyuki |
Organization
Nagasaki university
Division name
Department of Surgery
Zip code
8528102
Address
1-7-1 Sakamoto, Nagasakai city, Nagasaki, Japan
TEL
0958197317
Homepage URL
t-adachi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasakai city, Nagasaki, Japan
Tel
095-819-7726
rinshou7726@umin.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
| 2022 | Year | 07 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2022 | Year | 07 | Month | 13 | Day |
Last modified on
| 2022 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055124
