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)

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 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


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

Value
https://center6.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