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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027823
Receipt No. R000031878
Scientific Title Multi-center retrospective study of prognostic significance of histological subtypes and expression of immunomolecules in adenocarcinoma of the uterine cervix
Date of disclosure of the study information 2017/06/19
Last modified on 2017/06/19

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Basic information
Public title Multi-center retrospective study of prognostic significance of histological subtypes and expression of immunomolecules in adenocarcinoma of the uterine cervix
Acronym Prognostic significance of histological subtypes and expression of immunomolecules in adenocarcinoma of the uterine cervix
Scientific Title Multi-center retrospective study of prognostic significance of histological subtypes and expression of immunomolecules in adenocarcinoma of the uterine cervix
Scientific Title:Acronym Prognostic significance of histological subtypes and expression of immunomolecules in adenocarcinoma of the uterine cervix
Region
Japan

Condition
Condition Adenocacinoma of the uterine cervix
Classification by specialty
Obsterics and gynecology Radiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate correlations between subtypes and immunomolecules expression of adenocarcinoma of the uterine cervix and the prognoses after definitive radiotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 5-year 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 Female
Key inclusion criteria (1)Adenocarcinoma of the uterine cervix
(2)treated with definitive radiotherapy in the institutions between 2000 and 2016
Key exclusion criteria (1)prior treatment
(2)no bioptic sample
(3)other malignancies (except no recurrence cases 5 years after definitive treatments)
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi NAKANO
Organization Gunma university hospital
Division name department of radiation oncology
Zip code
Address 3-39-22, Showa-machi, Maebashi City, Gunma pref., Japan
TEL +81-27-220-8383
Email tnakano@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuya YOSHIMOTO
Organization Gunma university hospital
Division name department of radiation oncology
Zip code
Address 3-39-22, Showa-machi, Maebashi City, Gunma pref., Japan
TEL +81-27-220-8383
Homepage URL
Email yuyayoshimoto@gunma-u.ac.jp

Sponsor
Institute Gunma university
Institute
Department

Funding Source
Organization Gunma university
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor (1)Hospital, National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
(2)Gunma prefectural cancer center
(3)Saitama cancer center
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 群馬大学医学部附属病院(群馬県)
量子科学技術研究開発機構 放射線医学総合研究所病院(千葉県)
群馬県立がんセンター(群馬県)
埼玉県立がんセンター(埼玉県)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 19 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 Open public recruiting
Date of protocol fixation
2017 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Multi-center prospective observational study
period:2000-2016

Management information
Registered date
2017 Year 06 Month 19 Day
Last modified on
2017 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031878

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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