UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003202
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

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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

Obstetrics 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 Shu-Yuan
Middle name
Last name Liao

Organization

ST. JOSEPH HOSPITAL

Division name

Department of Pathology

Zip code

92868

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 Nobuyuki
Middle name
Last name Susumu

Organization

Keio University, School of Medicine

Division name

Department of Obstetrics & Gynecology

Zip code

160-0016

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-3353-1211

Homepage URL

http://www.gog.org

Email

nrg-japan@kuhs.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

USA


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine Ethics Committee

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp


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

No longer recruiting

Date of protocol fixation

2009 Year 02 Month 09 Day

Date of IRB

2009 Year 12 Month 26 Day

Anticipated trial start date

2010 Year 06 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

2024 Year 02 Month 15 Day



Link to view the page

Value
https://center6.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