UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025836 |
|---|---|
| Receipt number | R000029601 |
| Scientific Title | The identification of the precursor lesion in high grade serous carcinogenesis |
| Date of disclosure of the study information | 2017/01/25 |
| Last modified on | 2020/03/28 13:38:59 |
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Basic information
Public title
The identification of the precursor lesion in high grade serous carcinogenesis
Acronym
The identification of the precursor lesion in high grade serous carcinogenesis
Scientific Title
The identification of the precursor lesion in high grade serous carcinogenesis
Scientific Title:Acronym
The identification of the precursor lesion in high grade serous carcinogenesis
Region
| Japan |
Condition
Condition
High grade serous carcinoma
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the relation between TP53 mutation status and high grade serous carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Tumor histology and cell proliferation, expression profile of cancer-related gene, response rate of chemotherapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Surgical cases in Gifu University Hospital
2. Histological confirmation of high grade serous carcinoma
3. Written informed consent
Key exclusion criteria
Inappropriate surgical materials for histological and molecular biological analysis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Hatano |
Organization
Gifu University Graduate School of Medicine
Division name
Tumor Pathology
Zip code
501-1194
Address
1-1 Yanagido, Gifu, 501-1194, Japan
TEL
058-230-6225
yuha@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Hatano |
Organization
Gifu University Hospital
Division name
Pathology Division
Zip code
5011194
Address
1-1 Yanagido, Gifu, 501-1194, Japan
TEL
058-230-7244
Homepage URL
yuha@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
independent Ethics Committee, Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu, Gifu
Tel
0582306059
rinri@gifu-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
岐阜大学医学部附属病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 25 | 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
39
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
| 2016 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 28 | Day |
Other
Other related information
TP53 mutation status
Histological and immunohistochemical characteristics
Expression profile of cancer-related genes
Response rate of chemotherapy
Prognosis
Management information
Registered date
| 2017 | Year | 01 | Month | 25 | Day |
Last modified on
| 2020 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029601
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
