UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037919 |
|---|---|
| Receipt number | 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 | 2023/03/07 12:50:11 |
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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
| Obstetrics 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
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
kmurakami@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2019 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 04 | Day |
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
The study was terminated due to difficulties in implementing the research plan.
Not yet approved by IRB. Approval date was entered as a provisional date.
Management information
Registered date
| 2019 | Year | 09 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043221
