UMIN-CTR Clinical Trial

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 Takashi Middle name Last name NAKANO
Organization	Gunma university hospital
Division name	department of radiation oncology
Zip code	371-8511
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 Yuya Middle name Last name YOSHIMOTO
Organization	Gunma university hospital
Division name	department of radiation oncology
Zip code	371-8511
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	Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address	3-39-22 Showa-machi, Maebashi, Gunma, Japan
Tel	+81-27-220-8740
Email	hitotaisho-ciru@ml.gunma-u.ac.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	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	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	71
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 01 Month 11 Day
Date of IRB	2017 Year 01 Month 27 Day
Anticipated trial start date	2017 Year 01 Month 30 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	Multi-center prospective observational study period:2000-2016

Management information
Registered date	2017 Year 06 Month 19 Day
Last modified on	2021 Year 06 Month 17 Day

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