UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022481 |
|---|---|
| Receipt number | R000025902 |
| Scientific Title | Exploratory investigation of discovering novel biomarker to predict efficacy of chemotherapy ncluding bevacizumab in patients with advanced ovarian cancer |
| Date of disclosure of the study information | 2016/05/27 |
| Last modified on | 2024/05/07 09:29:53 |
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Basic information
Public title
Exploratory investigation of discovering novel biomarker to predict efficacy of chemotherapy ncluding bevacizumab in patients with advanced ovarian cancer
Acronym
Predictive therapeutic marker of bevacizumab against patients with ovarian cancer
Scientific Title
Exploratory investigation of discovering novel biomarker to predict efficacy of chemotherapy ncluding bevacizumab in patients with advanced ovarian cancer
Scientific Title:Acronym
Predictive therapeutic marker of bevacizumab against patients with ovarian cancer
Region
| Japan |
Condition
Condition
Advanced ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Bevacizumab is an effective agent against a varisous human cancer, but there are no established biomarkers to predict its therapeutic efficacy. In the present study, our purpose is to explore the predictive marker after treatment including bevacizumab using blood sample and molecular imaging by FDG-PET.
Basic objectives2
Others
Basic objectives -Others
To monitor the outcome after treatment
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changeing of SUVmax, MTV and TLG, and the efficacy of bevacizumab
Evaluation after 1 month from administration of bevacizumab
Exploratory investigation of many biomarkers using blood sample
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
All patients undergo FDG-PET/MRI before and 4 weeks after initiation of bevacizumab therapy.
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
Male and Female
Key inclusion criteria
1) Pathologically confirmed advanced ovarian cancer with stage III/IV
2) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
3) Patient with evaluable lesion based on RECIST
4) Written informed consent
Key exclusion criteria
1) Pregnant woman
2) Patients with double primary cancer or serious infectious disease requring antibiotic therapy
3) Other cases attending physician it is determined unsuitable for registration of the study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Hirakawa |
Organization
Gunma Univetsity Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
Address
showa-machi, Meabasshi, Gunm , Japan
TEL
027-220-8438
tahirakawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma Univetsity
Division name
Department of Oncology Clinical Development
Zip code
Address
showa-machi, Meabasshi, Gunm , Japan
TEL
027-220-8222
Homepage URL
kkaira1970@yahoo.co.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
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
Address
Tel
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
| 2016 | Year | 05 | Month | 27 | 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
Suspended
Date of protocol fixation
| 2016 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025902
