UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040406 |
|---|---|
| Receipt number | R000046110 |
| Scientific Title | Multicenter observational study on treatment results for rectal cancer |
| Date of disclosure of the study information | 2020/05/14 |
| Last modified on | 2020/05/14 23:18:57 |
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Basic information
Public title
Multicenter observational study on treatment results for rectal cancer
Acronym
Multicenter observational study on treatment results for rectal cancer
Scientific Title
Multicenter observational study on treatment results for rectal cancer
Scientific Title:Acronym
Multicenter observational study on treatment results for rectal cancer
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the 5-year overall survival rate of laparoscopic surgery for rectal cancer at our hospital and related facilities with open surgery and to examine its validity in a retrospective, prospective, multicenter observational study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Five-year overall survival rate of laparoscopic surgery group and open surgery group
Key secondary outcomes
Comparative study of 5-year recurrence-free survival rate between laparoscopic surgery group and open surgery group
Safety and efficacy of preoperative treatment cases (adverse events, treatment completion rate, response rate, recurrence-free survival, overall survival, etc.)
Study on surgical procedure, postoperative complication rate, and risk factors for postoperative complications
Study on postoperative abdominal scar hernia
Whether postoperative adjuvant chemotherapy is performed and its details
Study on recurrence site and post-recurrence treatment
Effects of postoperative complications on long-term outcome
Treatment results of cases invading other organs
Treatment results of a case with distant metastasis (cStage IV)
Treatment results in obese cases (BMI, VFA, SFA)
Treatment results of laparoscopic surgery in the elderly
Treatment results of para-aortic lymph node dissection
Treatment results for patients with coexisting diseases (heart disease, lung disease, oral antiplatelet drug etc.)
Examination of the depth of primary lesion and the diagnostic ability of lateral lymph node metastasis by preoperative MRI
Short-term and long-term results of lateral dissection
Study on lymph node dissection effect using dissection index
Subgroup analysis
Analyze the above evaluation items for each subgroup such as tumor occupancy site and pStage
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
Rectal cancer patient
Key exclusion criteria
Patients who are judged as inappropriate by the doctor
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
232-0024
Address
4-57, Urafune-cho, Minami-ku
TEL
0452615656
nabe-jun@comet.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Watanabe |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
232-0024
Address
4-57, Urafune-cho, Minami-ku
TEL
0452615656
Homepage URL
nabe-jun@comet.ocn.ne.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
the institutional review board for studies in humans
Address
3-9 Fukuura, Kanazawa-ku
Tel
+81457872650
nabe-jun@comet.ocn.ne.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 | 05 | Month | 14 | 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
| 2018 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2020 | Year | 05 | Month | 14 | Day |
Last modified on
| 2020 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046110
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
