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CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells

Trial Status: Closed to Accrual

This research trial studies carbonic anhydrase 9 (CA-IX), p16, proliferative markers, and human papilloma virus (HPV) in diagnosing cervical lesions in patients with abnormal cervical cells. Studying biomarkers in abnormal cervical cells may improve the ability to find cervical lesions and plan effective treatment.

Inclusion Criteria

  • Patients with a cytologic diagnosis of AGC (AGC, atypical endocervical cells [AEC], atypical endometrial cells [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
  • 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

  • Patients who have had a hysterectomy
  • 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

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE
Contact: Shu-Yuan liao
University of Arizona Cancer Center-North Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-327-2873

California

La Jolla
UC San Diego Moores Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 858-822-5354
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-398-3996
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-798-0719
Orange
Saint Joseph Hospital - Orange
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 714-734-6220
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-827-8839
Sylmar
Olive View-University of California Los Angeles Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 818-364-1555

Connecticut

Hartford
Hartford Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 860-545-5363
New Britain
The Hospital of Central Connecticut
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 860-224-5660

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Health - Coeur d'Alene
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Emmett
Walter Knox Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Meridian
Idaho Urologic Institute-Meridian
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Nampa
Saint Alphonsus Medical Center-Nampa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Post Falls
Kootenai Clinic Cancer Services - Post Falls
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

Illinois

Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 847-570-2109
Mount Vernon
Good Samaritan Regional Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-242-4600

Indiana

Elkhart
Elkhart Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-296-3903
Elkhart General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-296-6536
Michiana Hematology Oncology PC-Elkhart
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-389-0414
Kokomo
Community Howard Regional Health
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 765-453-8571
La Porte
IU Health La Porte Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 219-326-2683
Mishawaka
Michiana Hematology Oncology PC-Mishawaka
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-237-1328
Saint Joseph Regional Medical Center-Mishawaka
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-237-1328
Plymouth
Michiana Hematology Oncology PC-Plymouth
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-936-2585
South Bend
Memorial Hospital of South Bend
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-284-7370
Michiana Hematology Oncology PC-South Bend
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Eduardo Braun
Phone: 219-785-3400
South Bend Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 574-204-6192
Westville
Michiana Hematology Oncology PC-Westville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 219-785-3400

Kansas

Kansas City
Providence Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
Lenexa
Kansas Institute of Medicine Cancer and Blood Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Minimally Invasive Surgery Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Overland Park
Menorah Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Saint Luke's South Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Shawnee Mission
Advent Health - Shawnee Mission Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-676-2377

Louisiana

Baton Rouge
Woman's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 225-215-1353

Maine

Portland
Maine Medical Center-Bramhall Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 207-885-7565
Scarborough
Maine Medical Center- Scarborough Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 207-396-8090

Massachusetts

Springfield
Baystate Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 413-794-3565

Michigan

Niles
Lakeland Hospital Niles
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Royal Oak
William Beaumont Hospital-Royal Oak
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230
Marie Yeager Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 616-391-1230

Minnesota

Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-776-0015

Missouri

Independence
Centerpoint Medical Center LLC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Kansas City
Heartland Hematology and Oncology Associates Incorporated
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
North Kansas City Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 816-691-1599
Research Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Saint Joseph Health Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 816-943-2281
Saint Luke's Hospital of Kansas City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Truman Medical Centers
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 816-404-4375
Lee's Summit
Saint Luke's East - Lee's Summit
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Liberty
Liberty Radiation Oncology Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 913-948-5588
Rolla
Delbert Day Cancer Institute at PCRMC
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-458-7504
Mercy Clinic-Rolla-Cancer and Hematology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 573-458-7504
Saint Joseph
Heartland Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 816-271-7937
Saint Joseph Oncology Inc
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Rakesh Gaur
Phone: 913-948-5588
Saint Louis
Mercy Hospital Saint Louis
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 314-251-7066
Springfield
CoxHealth South Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 417-269-4520

Montana

Anaconda
Community Hospital of Anaconda
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Billings
Billings Clinic Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663
Saint Vincent Healthcare
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Bozeman
Bozeman Deaconess Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Butte
Saint James Community Hospital and Cancer Treatment Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Helena
Saint Peter's Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Saint Patrick Hospital - Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-327-3118

Nebraska

Omaha
University of Nebraska Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 402-559-6941

Nevada

Las Vegas
Women's Cancer Center of Nevada
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-693-6870

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-639-6918
Nashua
Norris Cotton Cancer Center-Nashua
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 603-577-4282

New Jersey

New Brunswick
Saint Peter's University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 732-745-8600ext6163
Newark
Rutgers New Jersey Medical School
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 732-235-8675

New York

Bronx
Montefiore Medical Center-Einstein Campus
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 718-379-6866
New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 212-305-6361
Rochester
University of Rochester
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 585-275-5830

North Carolina

Pinehurst
FirstHealth of the Carolinas-Moore Regional Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 910-715-3500
Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 336-713-6771

Ohio

Belpre
Strecker Cancer Center-Belpre
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-523-3977
Chillicothe
Adena Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 877-779-7585
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 513-558-4553
Columbus
Columbus Oncology and Hematology Associates Inc
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Doctors Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-566-3275
Grant Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-566-4475
Mount Carmel East Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Mount Carmel Health Center West
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-234-5433
Riverside Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-566-4475
The Mark H Zangmeister Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Delaware
Delaware Health Center-Grady Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-615-0227
Delaware Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Grady Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-615-2403
Dublin
Dublin Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-752-9119
Gahanna
Central Ohio Breast and Endocrine Surgery
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2745
Lancaster
Fairfield Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-687-8863
Mansfield
OhioHealth Mansfield Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 419-526-8018
Marietta
Marietta Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-523-3977
Marion
OhioHealth Marion General Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Mount Vernon
Knox Community Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-393-9000
Newark
Licking Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-348-4000
Newark Radiation Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Portsmouth
Southern Ohio Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-488-2118
Westerville
Saint Ann's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 614-234-5433
Zanesville
Genesis Healthcare System Cancer Care Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 740-454-5232

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 405-271-8777
Tulsa
Oklahoma Cancer Specialists and Research Institute-Tulsa
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 918-505-3200

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Ontario
Saint Alphonsus Medical Center-Ontario
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671

Pennsylvania

Danville
Geisinger Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-459-2901
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-374-8555
Lewistown
Lewistown Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 717-242-7703
Philadelphia
Temple University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 215-728-2983
Pottsville
Geisinger Cancer Services-Pottsville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-275-6401
Scranton
Community Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-703-4768
Selinsgrove
Geisinger Medical Oncology-Selinsgrove
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-374-8555
State College
Geisinger Medical Group
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 570-271-5251

Rhode Island

Providence
Women and Infants Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 401-274-1122

South Carolina

Anderson
AnMed Health Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-512-4651
Greenville
Saint Francis Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-603-6213
Spartanburg
Spartanburg Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 864-560-6104

South Dakota

Sioux Falls
Avera Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-634-7268

Texas

Galveston
University of Texas Medical Branch
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 409-772-1950
Houston
Memorial Hermann Texas Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 713-792-3245
League City
UTMB Cancer Center at Victory Lakes
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-917-8906

Wyoming

Cody
Big Horn Basin Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
Billings Clinic-Cody
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-996-2663
Sheridan
Welch Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060

Japan

Akashi-city
Hyogo Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 81 78-929-1151
Hiroshima City
Hiroshima University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 82-424-6042
Kagoshima City
Kagoshima City Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 011 81 099 224 2101
Kure
Kure National Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: (0823) 22-3111
Matsuyama
Shikoku Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 089-999-1172
Minami-ku
National Kyushu Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 092-641-1151
Minato-ku, Tokyo
Jikei University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 03-3433-1111 ext 2153
Nakagami-gun
University of the Ryukyus Hospital-Col Health Scnc
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 098-895-3331
Niigata City
Niigata University Medical and Dental Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 81-025-223-6161
Osaka
Kindai University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 072-366-0221
Saitama
Saitama Medical University International Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 81-49-276-2028
Sapporo
Hokkaido University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Sendai
Tohoku University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Shinjuku-ku
Keio University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 03 5363-3848
Shiwa-gun
Iwate Medical University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 019-651-5111
Tokyo
National Cancer Center Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 81-3-3542-2511
Tottori
Tottori University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 0857-31-5007

Korea, Republic of

Dalseo-gu
Keimyung University-Dongsan Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ho@dsmc.or.kr
Goyang-si
National Cancer Center-Korea
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 82-31-920-1934
Incheon
Gachon University Gil Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 82-32-460-3213
Jung-gu
Inha University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
Seongnam City
Seoul National University Bundang Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 82-2-2072-2890
Seoul
Asan Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Catholic University of Korea-Seoul Saint Mary's Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 2258-5745-6
Gangnam Severance Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 82-2-2019-3600
Kyung Hee University Hospital at Gangdong
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 82-2-961-0554
Seoul National University Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 011-82-760-2384
Yonsei University Health System-Severance Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ihcc@yuhs.ac

PRIMARY OBJECTIVES:

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.

Trial Phase Phase NA

Trial Type Ancillary-correlative

Lead Organization
Gynecologic Oncology Group

Principal Investigator
Shu-Yuan liao

  • Primary ID GOG-0237
  • Secondary IDs NCI-2009-01103, CDR0000632236
  • Clinicaltrials.gov ID NCT00892866