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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003341
Receipt No. R000004051
Scientific Title The study of an evaluation for gynecological tumor
Date of disclosure of the study information 2010/04/01
Last modified on 2016/03/16

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Basic information
Public title The study of an evaluation for gynecological tumor
Acronym PET study for gynecological tumor
Scientific Title The study of an evaluation for gynecological tumor
Scientific Title:Acronym PET study for gynecological tumor
Region
Japan

Condition
Condition ovarian cancer, cervical cancer, uterine coorpus cancer, other gynecological malignancies
Classification by specialty
Obsterics and gynecology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate treatment response of gynecological malignancies by PET
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes comparing response rate measured by CT and
prognosis with SUV mesured by PET
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Comitting PET before and after 1and 3 courses of a treatment
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Female
Key inclusion criteria patients with measurable gynecological malignancies
Key exclusion criteria Patients with severe Diabetes.
Performance Status >2
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Enomoto
Organization Osaka University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka, Suita-shi, Osaka, Japan
TEL 06-6879-3351
Email ZVF03563@nifty.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Enomoto
Organization Osaka University Graduate School of Medicine
Division name Department of Obstetrics and Gynecology
Zip code
Address 2-2 Yamadaoka, Suita-shi, Osaka, Japan
TEL 06-6879-3351
Homepage URL
Email enomoto@gyne.med.osaka-u.ac.jp

Sponsor
Institute Department of Obstetrics and Gynecology,Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Obstetrics and Gynecology,Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Nuclear Medicine and Tracer Kinetics, Osaka University Graduate School of Medicine
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 Osaka University Hospital

Other administrative information
Date of disclosure of the study information
2010 Year 04 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 Completed
Date of protocol fixation
2010 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 16 Day
Last modified on
2016 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004051

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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