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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name