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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000003202
Receipt No. R000003876
Scientific Title COMPARATIVE ANALYSIS OF CA-IX, p16, PROLIFERATIVE MARKERS AND HUMAN PAPILLOMA VIRUS (HPV) IN THE DIAGNOSIS OF SIGNIFICANT CERVICAL LESIONS IN PATIENTS WITH A CYTOLOGIC DIAGNOSIS OF ATYPICAL GLANDULAR CELLS (AGC)
Date of disclosure of the study information 2010/02/17
Last modified on 2018/08/27

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Basic information
Public title COMPARATIVE ANALYSIS OF CA-IX, p16, PROLIFERATIVE MARKERS AND HUMAN PAPILLOMA VIRUS (HPV) IN THE DIAGNOSIS OF SIGNIFICANT CERVICAL LESIONS IN PATIENTS WITH A CYTOLOGIC DIAGNOSIS OF ATYPICAL GLANDULAR CELLS (AGC)
Acronym GOG-0237
Scientific Title COMPARATIVE ANALYSIS OF CA-IX, p16, PROLIFERATIVE MARKERS AND HUMAN PAPILLOMA VIRUS (HPV) IN THE DIAGNOSIS OF SIGNIFICANT CERVICAL LESIONS IN PATIENTS WITH A CYTOLOGIC DIAGNOSIS OF ATYPICAL GLANDULAR CELLS (AGC)
Scientific Title:Acronym GOG-0237
Region
Japan Asia(except Japan) North America

Condition
Condition ATYPICAL GLANDULAR CELLS(AGC)
Adenocarcinoma In Situ(AIS)
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 1)To examine CA-IX, p16, Ki-67, and MCM2 expression in liquid-based cytology (LBC) specimens to see which subset of markers can provide the optimal diagnosis of significant cervical lesions in women in North America with a cytologic diagnosis of atypical glandular cells (AGC) and a positive test for high risk HPV.
2)To examine high risk HPV, CA-IX, p16, Ki-67, and MCM2 expression in LBC specimens to see which subset of markers can provide the optimal diagnosis of significant cervical lesions in women in Japan and Korea [with each country's cohort analyzed separately] with a cytologic diagnosis of AGC.
Basic objectives2 Others
Basic objectives -Others Diagnostic
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1)CA-IX , high-risk HPV, p16, Ki-67, and MCM2 expression as an optimal diagnosis of cervical lesions in patients in North America
2)CA-IX , high-risk HPV, p16, Ki-67, and MCM2 expression as an optimal diagnosis of cervical lesions in patients in Japan
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Gene Maneuver
Interventions/Control_1 DNA analysis, gene expression analysis, diagnostic laboratory biomarker analysis, immunohistochemistry staining method, cone biopsy, endocervical curettage, histopathologic examination, loop electrosurgical excision procedure
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 1)Patients with a cytologic diagnosis of AGC (AGC, AEC, AEmC) or a
cytologic/histologic diagnosis of AIS documented within the last 6 months who
can wait at least one week after the AGC or AIS diagnosis to have an LBC
specimen (i.e., ThinPrep) collected and then receive any other intervention.
Acceptable time frame range is 4 days prior to registration to 7 days after
registration.
2)Patients with positive HPV results who are willing to undergo a complete
histologic examination of the uterus and cervix, including the cervical
transformation zone, within 6 months of the AGC or AIS diagnosis (histologic
examination includes a LEEP, LETZ, excisional cone biopsy, or hysterectomy).
3)Patients who are 18 years of age or older.
4)Patients must have signed an approved informed consent and authorization
permitting release of personal health information.
Key exclusion criteria 1)Patients with a hysterectomy.
2)Patients with a history of endometrial hyperplasia or cancer of the endometrium, vagina or cervix.
3)Patients who have previously been, or are currently being treated with radiation therapy or chemotherapy for vaginal or cervical cancer.
4)Patients who are known to be HIV positive as these patients often have disease that is highly variable and aggressive resulting in rapid changes.
5)Patients who are pregnant and thought to be at risk for excessive bleeding or
preterm labor if cone biopsy is performed.
Target sample size 900

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shu-Yuan Liao, M.D.
Organization ST. JOSEPH HOSPITAL
Division name Department of Pathology
Zip code
Address 100 W. STEWART DRIVE, ORANGE, CA 92868, USA
TEL (714)771-8176
Email support@gogstats.org

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Susumu, M.D.,Ph.D.
Organization Keio University, School of Medicine
Division name Department of Obstetrics & Gynecology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL http://www.gog.org
Email nrg-japan@newkast.or.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 USA

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00892866
Org. issuing International ID_1 National Cancer Institute (NCI)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 慶應義塾大学病院(東京都)、埼玉医科大学国際医療センター(埼玉県)、鳥取大学附属病院(鳥取県)、東京慈恵会医科大学附属病院(東京都)、鹿児島市立病院(鹿児島県)、近畿大学医学部附属病院(大阪府)、国立がんセンター中央病院(東京都)、九州がんセンター(福岡県)、四国がんセンター(愛媛県)、東北大学病院(宮城県)、北海道大学病院(北海道)、呉医療センター・中国がんセンター(広島県)、岩手医科大学附属病院(岩手県)、広島大学病院(広島県)、新潟大学医歯学総合病院(新潟県)、琉球大学医学部附属病院(沖縄県)、兵庫県立がんセンター(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 17 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 Suspended
Date of protocol fixation
2009 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2016 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 17 Day
Last modified on
2018 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003876

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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