UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025726 |
|---|---|
| Receipt number | R000029534 |
| Scientific Title | A multi-institutional observational study on objective evaluation of peritoneal metastasis from colorectal cancer |
| Date of disclosure of the study information | 2017/01/18 |
| Last modified on | 2023/07/27 15:17:37 |
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Basic information
Public title
A multi-institutional observational study on objective evaluation of peritoneal metastasis from colorectal cancer
Acronym
A study on objective evaluation of peritoneal metastasis from colorectal cancer
Scientific Title
A multi-institutional observational study on objective evaluation of peritoneal metastasis from colorectal cancer
Scientific Title:Acronym
A study on objective evaluation of peritoneal metastasis from colorectal cancer
Region
| Japan |
Condition
Condition
Synchronous peritoneal metastasis from colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish a new classification of synchronous peritoneal metastasis from colorectal cancer.
Basic objectives2
Others
Basic objectives -Others
To clarify the association between outcomes after surgery for colorectal cancer with synchronous peritoneal metastasis and present classification of peritoneal metastasis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the association between 3-year overall survival rate and various clinicopathologic factors of synchronous peritoneal metastasis from colorectal cancer
Key secondary outcomes
Association between PCI and Japanese classification of peritoneal metastasis from colorectal cancer.
Association between degree of peritoneal metastasis and curative resection rate.
Association between chemothrerapy and prognosis.
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
1) Primary colorectal cancer
2) Pathologically proven as adenocarcinoma
3) Synchronous peritoneal metastasis from colorectal cancer
4) No multiple primaries within 5 years
5) Age of 20 or older
6) Obtaining informed consent.
Key exclusion criteria
1) Without informed consent.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kenjiro |
| Middle name | |
| Last name | Kotake |
Organization
Tochigi Cancer Center
Division name
Surgery
Zip code
320-0834
Address
4-9-13 Yonan, Utsunomiya, Tochigi, Japan
TEL
028-658-5151
kkotake@sea.ucatv.ne.jp
Public contact
Name of contact person
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Teikyo University, Mizonokuchi Hospital
Division name
Department of Surgery
Zip code
213-8507
Address
5-1-1 Futago, Kawasaki Takatsu-ku, Kanagawa, Japan
TEL
044-844-3333
Homepage URL
hkoba@med.teikyo-u.ac.jp
Sponsor or person
Institute
Japanese Society for Cancer of the Colon and Rectum
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Cancer of the Colon and Rectum
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Society for Cancer of the Colon and Rectum
Address
Sanbancho KS building, Sanbancho 2, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-8697
jsccr@secretariat.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
| 2017 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/ags3.12679
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/ags3.12679
Number of participants that the trial has enrolled
150
Results
The proposed classification was as follows
P0 no peritoneal metastases
P1 metastases localized to adjacent peritoneum (within two regions of PCI)
P2 metastases to distant peritoneum, number =<10 and size =<3 cm
P3 metastases to distant peritoneum, number =>11 or size >3 cm
P3a metastases to distant peritoneum, number =>11 and size =<3 cm, or number =<10 and size >3 cm
P3b metastases to distant peritoneum, number =>11 and size >3 cm.
Results date posted
| 2023 | Year | 07 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Between October 2012 and December 2016, 150 patients with synchronous peritoneal metastasis from colorectal cancer were enrolled.
Participant flow
Between October 2012 and December 2016, 150 patients with synchronous peritoneal metastasis from colorectal cancer were enrolled.
Adverse events
None
Outcome measures
Prognostic discrimination ability of present and new classification of peritoneal metastasis from colorectal cancer
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Observational items: Details of peritoneal metastasis from colorectal cancer, other clinicopathologic features
Management information
Registered date
| 2017 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029534
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