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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006760
Receipt No. R000007586
Scientific Title MORPHOMETRIC DIAGNOSIS OF ATYPICAL GLANDULAR LESIONS USING A CONVENTIONAL PAP SMEAR FROM GOG-0171 PATIENTS (ENROLLED BY GOG-JAPAN) WITH A CYTOLOGIC DIAGNOSIS OF ATYPICAL GLANDULAR CELLS OF UNSPECIFIED SIGNIFICANCE (AGUS)
Date of disclosure of the study information 2011/11/22
Last modified on 2013/12/25

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Basic information
Public title MORPHOMETRIC DIAGNOSIS OF ATYPICAL GLANDULAR LESIONS USING A CONVENTIONAL PAP SMEAR FROM GOG-0171 PATIENTS (ENROLLED BY GOG-JAPAN) WITH A CYTOLOGIC DIAGNOSIS OF ATYPICAL GLANDULAR CELLS OF UNSPECIFIED SIGNIFICANCE (AGUS)
Acronym GOG-8007
Scientific Title MORPHOMETRIC DIAGNOSIS OF ATYPICAL GLANDULAR LESIONS USING A CONVENTIONAL PAP SMEAR FROM GOG-0171 PATIENTS (ENROLLED BY GOG-JAPAN) WITH A CYTOLOGIC DIAGNOSIS OF ATYPICAL GLANDULAR CELLS OF UNSPECIFIED SIGNIFICANCE (AGUS)
Scientific Title:Acronym GOG-8007
Region
Japan

Condition
Condition AGUS
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the diagnostic accuracy of using previously reported morphometric criteria for chromatin distribution, shortest distance between nuclei and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from women with a cytologic diagnosis of AGUS to predict the presence of significant glandular lesions (adenocarcinoma in situ [AIS] or invasive cancer) and/or squamous lesions (cervical intraepithelial neoplasia [CIN2 or CIN3]) of the cervix.To optimize the diagnostic accuracy of using chromatin distribution, shortest distance between nuclei and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from women with a cytologic diagnosis of AGUS to predict the presence of significant glandular lesions (AIS or invasive cancer) and/or squamous lesions (CIN2 or CIN3) of the cervix.
Basic objectives2 Others
Basic objectives -Others Diagnosis
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To determine the diagnostic accuracy of using previously reported morphometric criteria for chromatin distribution, shortest distance between nuclei and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from women with a cytologic diagnosis of AGUS to predict the presence of significant glandular lesions (adenocarcinoma in situ [AIS] or invasive cancer) and/or squamous lesions (cervical intraepithelial neoplasia [CIN2 or CIN3]) of the cervix.
Key secondary outcomes To optimize the diagnostic accuracy of using chromatin distribution, shortest distance between nuclei and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from women with a cytologic diagnosis of AGUS to predict the presence of significant glandular lesions (AIS or invasive cancer) and/or squamous lesions (CIN2 or CIN3) of the cervix.

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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Women who were eligible and evaluable for the primary objective of GOG-0171, were enrolled by GOG-JAPAN, and submitted the original Pap smear used to define the cytological diagnosis of AGUS are eligible for this protocol.Women or guardians who provided informed consent and gave permission to use her specimens for future cancer research in GOG-0171.
Key exclusion criteria Women who were not eligible and evaluable for the primary objective of GOG-0171, were not enrolled by GOG-JAPAN, or did not submit the original Pap smear used to define the cytological diagnosis of AGUS are not eligible for this protocol. Women or guardians who withdrew consent for GOG-0171 or who did not give permission to use her specimens for future cancer research in GOG-0171.
When published on the website, in case there was opposition

Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TSUNEHISA KAKU, M.D., PH.D.
Organization KYUSHU UNIVERSITY
Division name DEPARTMENT OF HEALTH SCIENCES, FACULTY OF MEDICINE
Zip code
Address MAIDASHI 3-1-1, HIGASHI-KU STATISTICIAN FUKUOKA 812-8582
TEL 092-642-6708
Email GOG-JPN@insti.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name SUMIKO WATANABE
Organization KYUSHU UNIVERSITY
Division name DEPARTMENT OF HEALTH SCIENCES, FACULTY OF MEDICINE
Zip code
Address MAIDASHI 3-1-1, HIGASHI-KU STATISTICIAN FUKUOKA 812-8582
TEL 092-642-6700
Homepage URL http://www.shs.kyushu-u.ac.jp/app/modules/research/
Email GOG-JPN@insti.kitasato-u.ac.jp

Sponsor
Institute Gynecologic Oncology Group
Institute
Department

Funding Source
Organization Gynecologic Oncology Group
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor Japanese Gynecologic Oncology Group
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00898144
Org. issuing International ID_1 National Cancer Institute (NCI)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 九州大学(福岡県)、慶應義塾大学病院(東京都)、鳥取大学附属病院(鳥取県)、鹿児島市立病院(鹿児島県)、九州がんセンター(福岡県)、東北大学病院(宮城県)、川崎医科大学附属病院(岡山県)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 22 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 10 Month 19 Day
Date of IRB
Anticipated trial start date
2011 Year 11 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 To determine the diagnostic accuracy of using previously reported
morphometric criteria for chromatin distribution, shortest distance between
nuclei and/or the ratio of nucleoli area to nucleus area in a conventional Pap
smear from women with a cytologic diagnosis of AGUS to predict the presence
of significant glandular lesions (adenocarcinoma in situ [AIS] or invasive
cancer) and/or squamous lesions (cervical intraepithelial neoplasia [CIN2 or CIN3]) of the cervix.

Management information
Registered date
2011 Year 11 Month 22 Day
Last modified on
2013 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007586

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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