UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050237 |
|---|---|
| Receipt number | R000057157 |
| Scientific Title | Clinicopathological study on glassy cell carcinoma of the cervix |
| Date of disclosure of the study information | 2023/02/05 |
| Last modified on | 2025/03/27 17:20:06 |
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Basic information
Public title
Clinicopathological study on glassy cell carcinoma of the cervix
Acronym
JGOG1086S
Scientific Title
Clinicopathological study on glassy cell carcinoma of the cervix
Scientific Title:Acronym
JGOG1086S
Region
| Japan |
Condition
Condition
glassy cell carcinoma of the cervix
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to analyze prognosis of GCC of the cervix in Japan based on central pathological diagnosis.
Basic objectives2
Others
Basic objectives -Others
In addition, we will perform genetic analysis by next generation sequencing to discover biomarkers for better diagnosis, molecules related to prognosis and therapeutic targets.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of cancer treatment and overall survival between GCC group and non-GCC group in cases diagnosed as adenosquamous cell carcinoma
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 diagnosed as GCC of the cervix between January 2002 and December 2021 in participating institutions
Key exclusion criteria
Patients judged not to be suitable for participation in this study by investigators
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hidemichi |
| Middle name | |
| Last name | Watari |
Organization
Hokkaido University Graduate School of Medicine and Faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
0117065941
watarih@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yasunari |
| Middle name | |
| Last name | Ishizuka |
Organization
Hokkaido University Graduate School of Medicine and Faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo, Hokkaido, Japan
TEL
0117065941
Homepage URL
JGOG1086S@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Department of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine and Faculty of Medicine.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Institutional Review Board
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido
Tel
0117067636
crjimu@huhp.hokudai.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 05 | 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
133
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
| 2022 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2023 | Year | 02 | Month | 05 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057157
