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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029371
Receipt No. R000033566
Scientific Title A retrospective study for ovarian metastasis and metastasis to the inguinal lymph node
Date of disclosure of the study information 2017/10/02
Last modified on 2019/04/04

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Basic information
Public title A retrospective study for ovarian metastasis and metastasis to the inguinal lymph node
Acronym A retrospective study for ovarian metastasis and metastasis to the inguinal lymph node
Scientific Title A retrospective study for ovarian metastasis and metastasis to the inguinal lymph node
Scientific Title:Acronym A retrospective study for ovarian metastasis and metastasis to the inguinal lymph node
Region
Japan

Condition
Condition colon and rectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the clinicopathological features and prognosis of ovarian metastasis, metastasis to inguinal lymph nodes.
Basic objectives2 Others
Basic objectives -Others Epidemiological survey
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes ovarian metastasis:3 years overall survival
metastasis to inguinal lymph nodes:5 years overall survival
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Ovarian metastasis
1.The case of Ovarian metastasis diagnosed between 1 January 2000 and 31 December 2014.
2.The primary tumor was histologically diagnosed as adenocarcinoma of colon and rectal cancer.

Inguinal lymph node metastasis
1.The case of lymph node metastasis diagnosed between 1 January 1997 and 31 December 2011.
2.The primary tumor is histologically diagnosed as rectal cancer and anal canal cancer.
Key exclusion criteria Ovarian metastasis
1.A case of ovariectomy due to other diseases
2.Primary tumor is appendice carcinoma
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Yusuke
Middle name
Last name Kinugasa
Organization Tokyo Medical and Dental University
Division name Department of Gastrointestinal Surgery
Zip code 113-8519
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL 03-5803-5254
Email kinugasa.srg1@tmd.ac.jp

Public contact
Name of contact person
1st name Hiroyasu
Middle name
Last name Kagawa
Organization Shizuoka Cancer Center Hospital
Division name Division of colon and rectal cancer
Zip code 411-8777
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan
TEL 055-989-5222
Homepage URL http://jsccr.jp/project/proj_ovary.html
Email h.kagawa@scchr.jp

Sponsor
Institute Japanese society for cancer of colon and rectum
Institute
Department

Funding Source
Organization Japanese society for cancer of 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 colon and rectum
Address 3 bancho, 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 静岡県立静岡がんセンター

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 02 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 300
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
2017 Year 09 Month 02 Day
Date of IRB
2017 Year 09 Month 12 Day
Anticipated trial start date
2017 Year 09 Month 12 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multi-center retrospective cohort study

Management information
Registered date
2017 Year 10 Month 01 Day
Last modified on
2019 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033566

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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