Unique ID issued by UMIN | UMIN000003202 |
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Receipt number | 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 | 2024/02/15 15:04:57 |
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)
GOG-0237
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)
GOG-0237
Japan | Asia(except Japan) | North America |
ATYPICAL GLANDULAR CELLS(AGC)
Adenocarcinoma In Situ(AIS)
Obstetrics and Gynecology |
Malignancy
YES
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.
Others
Diagnostic
Not applicable
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Diagnosis
Gene | Maneuver |
DNA analysis, gene expression analysis, diagnostic laboratory biomarker analysis, immunohistochemistry staining method, cone biopsy, endocervical curettage, histopathologic examination, loop electrosurgical excision procedure
18 | years-old | <= |
Not applicable |
Female
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.
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.
900
1st name | Shu-Yuan |
Middle name | |
Last name | Liao |
ST. JOSEPH HOSPITAL
Department of Pathology
92868
100 W. STEWART DRIVE, ORANGE, CA 92868, USA
(714)771-8176
support@gogstats.org
1st name | Nobuyuki |
Middle name | |
Last name | Susumu |
Keio University, School of Medicine
Department of Obstetrics & Gynecology
160-0016
35 Shinanomachi, Shinjuku-ku, Tokyo
03-3353-1211
http://www.gog.org
nrg-japan@kuhs.ac.jp
Gynecologic Oncology Group
Gynecologic Oncology Group
Outside Japan
USA
Keio University School of Medicine Ethics Committee
35 Shinanomachi, Shinjuku-ku, Tokyo
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
YES
NCT00892866
National Cancer Institute (NCI)
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)
2010 | Year | 02 | Month | 17 | Day |
Unpublished
No longer recruiting
2009 | Year | 02 | Month | 09 | Day |
2009 | Year | 12 | Month | 26 | Day |
2010 | Year | 06 | Month | 01 | Day |
2016 | Year | 12 | Month | 01 | Day |
2010 | Year | 02 | Month | 17 | Day |
2024 | Year | 02 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003876
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