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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037919
Receipt No. R000043221
Scientific Title Research on resistance mechanism after olaparib maintenance therapy for ovarian cancer
Date of disclosure of the study information 2019/10/01
Last modified on 2019/09/04

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Basic information
Public title Research on resistance mechanism after olaparib maintenance therapy for ovarian cancer
Acronym Research on resistance mechanism after olaparib maintenance therapy for ovarian cancer
Scientific Title Research on resistance mechanism after olaparib maintenance therapy for ovarian cancer
Scientific Title:Acronym Research on resistance mechanism after olaparib maintenance therapy for ovarian cancer
Region
Japan

Condition
Condition Ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Elucidation of the mechanism to acquire resistance after olaparib administration by gene mutation analysis
Basic objectives2 Others
Basic objectives -Others Gene mutations; BRCA1,BRCA2,TP53,PALB2,ATM,CDK12,CHEK2,EGFR,EZH2,PARP1,RAD51C,RAD51D
DNA methylations; BRCA1,RAD51C,SLFN11,SLC44A2,SLC44A3,CDH4,HRCT1
microRNA; genome-wide comprehensive analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gene mutation before and after olaparib administration
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) Collect blood samples before starting the first treatment in all cases clinically diagnosed with advanced ovarian cancer. In addition, tumor frozen specimens prior to initial drug therapy will be collected.
(2) Collect cancer-collected blood samples for all cases diagnosed with platinum-sensitive recurrent ovarian cancer. Furthermore, if the tumor tissue at the time of recurrence is collected by surgery or biopsy, the frozen tumor sample is collected.
(3) Collect blood samples before the start of olaparib as maintenance therapy for initial treatment or platinum-sensitive recurrence.
(4) Collect blood samples when recurrence or exacerbation is observed after olaparib as maintenance therapy at the first treatment or platinum-sensitive recurrence. If the tumor tissue at the time of recurrence or exacerbation after olaparib administration is collected by surgery or biopsy, a frozen tissue sample is also collected.
Key exclusion criteria Excluded if patient consent has not been obtained for participation in this study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Noriomi
Middle name
Last name Matsumura
Organization Kindai University Faculty of Medicine
Division name Department of Obstetrics & Gynecology
Zip code 589-8511
Address 377-2,Oonohigashi, Osakasayama, Osaka
TEL 072-366-0221
Email noriomi@med.kindai.ac.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Murakami
Organization Kindai University Faculty of Medicine
Division name Department of Obstetrics & Gynecology
Zip code 589-8511
Address 377-2,Oonohigashi, Osakasayama, Osaka
TEL 072-366-0221
Homepage URL
Email kmurakami@med.kindai.ac.jp

Sponsor
Institute Kindai University
Institute
Department

Funding Source
Organization Self funding
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 Kindai University Faculty of Medicine Institutional Review Board
Address 377-2,Oonohigashi, Osakasayama, Osaka
Tel 072-366-0221
Email zizen@med.kindai.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
2019 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2019 Year 09 Month 04 Day
Last modified on
2019 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043221

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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