UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000587 |
|---|---|
| Receipt number | 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 11:23:55 |
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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
| Obstetrics 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)
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
fujiit@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000712
