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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026070
Receipt No. R000029952
Scientific Title Multi-institutional prospective study on the usefulness of peritoneal lavagte cytology in patients with curative resection for colorectal cancer
Date of disclosure of the study information 2017/02/09
Last modified on 2018/10/04

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Basic information
Public title Multi-institutional prospective study on the usefulness of peritoneal lavagte cytology in patients with curative resection for colorectal cancer
Acronym PEC-CC
Scientific Title Multi-institutional prospective study on the usefulness of peritoneal lavagte cytology in patients with curative resection for colorectal cancer
Scientific Title:Acronym PEC-CC
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of peritoneal lavagte cytology in patients with curative resection for colorectal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5 year relapse-free survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 peritoneal lavage cytology during surgery for colorectal cancer
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) colorectal cancer which is proven by histopathologically
2) age 20 and older
3) informed consent before surgery
4) no malignancy past 5 years
5) cStage II or cStage III colorectal cancer
Key exclusion criteria patients without preoperative informed consent
Target sample size 2000

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 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 02 Month 09 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 No longer recruiting
Date of protocol fixation
2013 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 09 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=R000029952

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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