UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026070 |
|---|---|
| Receipt number | 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 | 2020/08/13 09:29:33 |
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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 | 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
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 Soceity 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 | 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
1785
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
| 2013 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
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
| 2020 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029952
