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Recruitment status
Unique ID issued by UMIN UMIN000000587
Receipt No. R000000712
Scientific Title Genetic analysis of gynecologic malignancies by BAC-microarray comparative genome hybridization analysis
Date of disclosure of the study information 2007/01/31
Last modified on 2007/01/30

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Basic information
Public title Genetic analysis of gynecologic malignancies by BAC-microarray comparative genome hybridization analysis
Acronym Array-CGH analysis of gynecologic malignancies
Scientific Title Genetic analysis of gynecologic malignancies by BAC-microarray comparative genome hybridization analysis
Scientific Title:Acronym Array-CGH analysis of gynecologic malignancies
Region
Japan

Condition
Condition Gynecologic malignancies
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To perform genome-wide detection of copy number abnormalities in gynecologic cancer tissues by BAC-microarray CGH method. To analyze expression patterns of genes and proteins of the tissues using expression array and antibody array.
Basic objectives2 Others
Basic objectives -Others To discover new cancer relating genes and proteins.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To obtain array-CGH data against cervical cancer, endometrial cancer, and ovarian cancer (50 cases each).
Key secondary outcomes To obtain data about frequencies and combinations of genomic alterations in the known cancer related locus. To identify new cancer related locus.

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 Cases of gynecologic malignancies for which surgical removals are performed.
Key exclusion criteria None.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuma Fujii/Shuichi Asakawa
Organization Keio University School of Medicine
Division name Department of obstetrics and gynecology/Department of molecular biology
Zip code
Address 35 Shinanomachi, Shinjuku-ku Tokyo 160-8582, Japan
TEL 03-3353-1211(62397.62726)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takuma Fujii
Organization Keio University School of Medicine
Division name Department of obstetrics and gynecology
Zip code
Address 35 Shinanomachi, Shinjuku-ku Tokyo 160-8582, Japan
TEL 03-3353-1211(62397)
Homepage URL
Email fujiit@sc.itc.keio.ac.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2007 Year 01 Month 31 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
Date of protocol fixation
2006 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospectively observe association between CGH result and convalescence.

Management information
Registered date
2007 Year 01 Month 30 Day
Last modified on
2007 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000712

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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