CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells
NCT ID: NCT00892866
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
877 participants
INTERVENTIONAL
2009-04-13
2025-05-31
Brief Summary
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Detailed Description
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I. To examine CA-IX, p16, Ki-67, and mini-chromosome maintenance complex component 2 (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 human papillomavirus (HPV).
II. 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.
SECONDARY OBJECTIVES:
I. To determine whether the accuracy of diagnosis based on high risk HPV and expression of CA-IX, p16, Ki-67, and/or MCM2 varies with patient age at enrollment and country of enrollment.
TERTIARY OBJECTIVES:
I. To assess biomarker expression, loss of heterozygosity, and chromosome gains/losses in formalin-fixed, paraffin-embedded tissue from the highest grade or most abnormal lesion in women from North America, Japan, or Korea presenting with a cytologic diagnosis of AGC or with a cytologic/histologic diagnosis of adenocarcinoma in situ (AIS).
II. To determine CA-IX, p16, Ki67, and MCM2 expression in LBC specimens to see which subset (or combination) of markers will provide higher sensitivity in the diagnosis of cervical adenocarcinoma in situ (AIS).
OUTLINE:
Patients undergo liquid-based cytology specimen sample collection for analysis of CA-IX, p16, Ki-67, and MCM2 expression via immunohistochemistry (IHC) and for the presence of high risk HPV deoxyribonucleic acid (DNA) and HPV genotyping.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Ancillary-Correlative (biomarkers in cervical cancer)
Patients undergo liquid-based cytology specimen sample collection for analysis of CA-IX, p16, Ki-67, and MCM2 expression via IHC and for the presence of high risk HPV DNA and HPV genotyping.
Cytology Specimen Collection Procedure
Correlative studies
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Cytology Specimen Collection Procedure
Correlative studies
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 loop electrosurgical excision procedure \[LEEP\], loop excision of the transformation zone \[LETZ\], excisional cone biopsy, or hysterectomy)
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria
* History of endometrial hyperplasia or cancer of the endometrium, vagina, or cervix
* Patients who have previously been treated, or are currently being treated with radiation therapy or chemotherapy for vaginal or cervical cancer
* Patients who are known to be human immunodeficiency virus (HIV)-positive
* Patients who are pregnant and thought to be at risk for excessive bleeding or preterm labor if a cone biopsy is performed
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
GOG Foundation
NETWORK
Responsible Party
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Principal Investigators
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Shu-Yuan liao
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Oncology Group
Locations
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Banner University Medical Center - Tucson
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Saint Joseph Hospital - Orange
Orange, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States
Hartford Hospital
Hartford, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Walter Knox Memorial Hospital
Emmett, Idaho, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, United States
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Cancer Clinic
Sandpoint, Idaho, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Elkhart Clinic
Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States
Providence Medical Center
Kansas City, Kansas, United States
Kansas Institute of Medicine Cancer and Blood Center
Lenexa, Kansas, United States
Minimally Invasive Surgery Hospital
Lenexa, Kansas, United States
Menorah Medical Center
Overland Park, Kansas, United States
Saint Luke's South Hospital
Overland Park, Kansas, United States
Advent Health - Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States
Woman's Hospital
Baton Rouge, Louisiana, United States
Maine Medical Center-Bramhall Campus
Portland, Maine, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Lakeland Hospital Niles
Niles, Michigan, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Centerpoint Medical Center LLC
Independence, Missouri, United States
Truman Medical Centers
Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Saint Joseph Health Center
Kansas City, Missouri, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Liberty Radiation Oncology Center
Liberty, Missouri, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Norris Cotton Cancer Center-Nashua
Nashua, New Hampshire, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States
Mount Carmel East Hospital
Columbus, Ohio, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
The Mark H Zangmeister Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States
Delaware Radiation Oncology
Delaware, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Dublin Methodist Hospital
Dublin, Ohio, United States
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
OhioHealth Marion General Hospital
Marion, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Newark Radiation Oncology
Newark, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon, United States
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, United States
Lewistown Hospital
Lewistown, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, United States
Community Medical Center
Scranton, Pennsylvania, United States
Geisinger Medical Oncology-Selinsgrove
Selinsgrove, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
University of Texas Medical Branch
Galveston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
UTMB Cancer Center at Victory Lakes
League City, Texas, United States
Big Horn Basin Cancer Center
Cody, Wyoming, United States
Billings Clinic-Cody
Cody, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Tohoku University School of Medicine
Sendai, Aoba-ku, Japan
Kure National Hospital
Kure, Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate, Japan
Kagoshima City Hospital
Kagoshima, Kagoshima-ken, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
University of the Ryukyus Hospital-Col Health Scnc
Nakagami-gun, Okinawa, Japan
Keio University
Shinjuku-ku, Tokyo, Japan
Hiroshima University Hospital
Hiroshima, , Japan
Shikoku Cancer Center
Matsuyama, , Japan
National Kyushu Cancer Center
Minamiku, , Japan
Jikei University School of Medicine
Minato-ku, Tokyo, , Japan
Kindai University
Osaka, , Japan
Saitama Medical University International Medical Center
Saitama, , Japan
National Cancer Center Hospital
Tokyo, , Japan
Tottori University
Tottori, , Japan
Keimyung University-Dongsan Medical Center
Dalseo-gu, Daegu, South Korea
National Cancer Center-Korea
Goyang-si, Gyeonggi-do, South Korea
Inha University
Jung-gu, Incheon, South Korea
Catholic University of Korea-Seoul Saint Mary's Hospital
Seoul, Korea, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyeonggi-do, South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Health System-Severance Hospital
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Countries
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Other Identifiers
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NCI-2009-01103
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000632236
Identifier Type: -
Identifier Source: secondary_id
GOG-0237
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0237
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0237
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0237
Identifier Type: -
Identifier Source: org_study_id
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