UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027823 |
|---|---|
| Receipt number | 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 | 2021/06/17 14:35:42 |
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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
| Obstetrics 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
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
yuyayoshimoto@gunma-u.ac.jp
Sponsor or person
Institute
Gunma university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031878
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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