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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025726
Receipt No. 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 2018/10/04

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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
Middle name
Last name Kenjiro Kotake
Organization Tochigi Cancer Center
Division name Surgery
Zip code
Address 4-9-13 Yonan, Utsunomiya, Tochigi, Japan
TEL 028-658-5151
Email kkotake@sea.ucatv.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotoshi Kobayashi
Organization Tokyo Metropolitan Hiroo Hospital
Division name Department of Surgery
Zip code
Address 2-34-10 Ebisu, Shibuya-ku, Tokyo, Japan
TEL 03-3444-1181
Homepage URL
Email hirotoshi_kobayashi@tmhp.jp

Sponsor
Institute Japanese Society for Cancer of the Colon and Rectum
Institute
Department

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
Address
Tel
Email

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
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2012 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2018 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029534

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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