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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007987
Receipt No. R000009399
Scientific Title Study of endocervical adenocarcinoma with gastric morphology and phenotype
Date of disclosure of the study information 2012/06/01
Last modified on 2015/04/08

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Basic information
Public title Study of endocervical adenocarcinoma with gastric morphology and phenotype
Acronym Study of gastric-type adenocarcinoma
Scientific Title Study of endocervical adenocarcinoma with gastric morphology and phenotype
Scientific Title:Acronym Study of gastric-type adenocarcinoma
Region
Japan

Condition
Condition uterine cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the hypothesis that gastric type adenocarcinoma is a morphologically and immunohistchemically distinct subset of endocervical adenocarcinoma characterized by aggressive clinical course
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate survival of gastric-type adenocarcinama and non gastric-type adenocarcinama
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 Female
Key inclusion criteria Patients of endocervical adenocarcinoma who received primary treatment during 2000 and 2009
Key exclusion criteria None
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiharu Kamura
Organization Kurume University School of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL 0942-31-7573
Email tkamura@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shin Nishio
Organization Kurume University School of Medicine
Division name Obstetrics and Gynecology
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL 0942-31-7573
Homepage URL
Email shinshin@med.kurume-u.ac.jp

Sponsor
Institute Gynecologic Cancer Study Group of Japan Clinical Oncology Group
Institute
Department

Funding Source
Organization National Cancer Center
Organization
Division
Category of Funding Organization
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
2012 Year 06 Month 01 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 Completed
Date of protocol fixation
2011 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 04 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 The medical record of each patient will be reviewed in treated institute with the name and ID numbers kept anonyomously.

Management information
Registered date
2012 Year 05 Month 18 Day
Last modified on
2015 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009399

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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