UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006760 |
|---|---|
| Receipt number | 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 10:24:18 |
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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
| Obstetrics 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
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/
GOG-JPN@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Gynecologic Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.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 |
