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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025836
Receipt No. 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 2019/02/27

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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
Obsterics 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
Middle name
Last name Yuichiro Hatano
Organization Gifu University Graduate School of Medicine
Division name Tumor Pathology
Zip code
Address 1-1 Yanagido, Gifu, 501-1194, Japan
TEL 058-230-6225
Email yuha@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichiro Hatano
Organization Gifu University Hospital
Division name Pathology Division
Zip code
Address 1-1 Yanagido, Gifu, 501-1194, Japan
TEL 058-230-7244
Homepage URL
Email yuha@gifu-u.ac.jp

Sponsor
Institute Gifu University Graduate School of Medicine
Institute
Department

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
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 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
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
2016 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 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
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029601

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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