CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells
Conditions
Atypical Endocervical Glandular Cell of Undetermined Significance - Atypical Endometrial Hyperplasia - Human Papillomavirus Infection - Stage 0 Cervical Cancer
Conditions: official terms
Cervical Intraepithelial Neoplasia - Endometrial Hyperplasia - Hyperplasia - Papillomavirus Infections - Uterine Cervical Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: Cytology Specimen Collection Procedure Type: Other
Name: Laboratory Biomarker Analysis Type: Other
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Locations
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Status: Active, not recruiting
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States
Status: Recruiting
Contact: Shu-Yuan Liao - syliao@uci.edu
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Status: Recruiting
Contact: Scott E. Lentz - 626-564-3455
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Status: Recruiting
Contact: Robin Farias-Eisner - 888-798-0719
Saint Joseph Hospital - Orange
Orange, California, United States
Status: Recruiting
Contact: Shu-Yuan Liao - 714-734-6220
University of California San Diego
San Diego, California, United States
Status: Recruiting
Contact: Michael T. McHale - 858-822-5354 - cancercto@ucsd.edu
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States
Status: Recruiting
Contact: Christine H. Holschneider - 888-798-0719
Hartford Hospital
Hartford, Connecticut, United States
Status: Recruiting
Contact: James S. Hoffman - 860-224-5660
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Status: Recruiting
Contact: James S. Hoffman - 860-224-5660
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Status: Active, not recruiting
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Status: Active, not recruiting
Elkhart Clinic
Elkhart, Indiana, United States
Status: Terminated
Elkhart General Hospital
Elkhart, Indiana, United States
Status: Terminated
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Status: Recruiting
Contact: Michael Rodriguez - 574-237-1328
Community Howard Regional Health
Kokomo, Indiana, United States
Status: Terminated
IU Health La Porte Hospital
La Porte, Indiana, United States
Status: Terminated
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Status: Recruiting
Contact: Michael Rodriguez - 574-237-1328
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Status: Terminated
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Status: Recruiting
Contact: Michael Rodriguez - 574-237-1328
Memorial Hospital of South Bend
South Bend, Indiana, United States
Status: Terminated
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
Status: Recruiting
Contact: Michael Rodriguez - 574-237-1328
Northern Indiana Cancer Research Consortium CCOP
South Bend, Indiana, United States
Status: Recruiting
Contact: Michael Rodriguez - 574-237-1328
South Bend Clinic
South Bend, Indiana, United States
Status: Terminated
Michiana Hematology Oncology-PC Westville
Westville, Indiana, United States
Status: Recruiting
Contact: Michael Rodriguez - 574-237-1328
Providence Medical Center
Kansas City, Kansas, United States
Status: Terminated
Menorah Medical Center
Overland Park, Kansas, United States
Status: Recruiting
Contact: Rakesh Gaur - 913-948-5588 - aroland@kccop.org
Saint Luke's South Hospital
Overland Park, Kansas, United States
Status: Recruiting
Contact: Rakesh Gaur - 913-948-5588 - aroland@kccop.org
Kansas City CCOP
Prairie Village, Kansas, United States
Status: Terminated
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States
Status: Terminated
Maine Medical Center-Bramhall Campus
Portland, Maine, United States
Status: Terminated
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States
Status: Recruiting
Contact: Laurie A. Small - 207-885-7565
Baystate Medical Center
Springfield, Massachusetts, United States
Status: Recruiting
Contact: Tashanna K. Myers - 413-794-3565 - tamara.wrenn@baystatehealth.org
Lakeland Community Hospital
Niles, Michigan, United States
Status: Recruiting
Contact: Michael Rodriguez - 574-237-1328
Michiana Hematology Oncology PC-Niles
Niles, Michigan, United States
Status: Terminated
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States
Status: Active, not recruiting
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Status: Withdrawn
Lakeland Hospital
St. Joseph, Michigan, United States
Status: Recruiting
Contact: Michael Rodriguez - 574-237-1328
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Contact: Jamie N. Bakkum-Gamez - 507-538-7623
Centerpoint Medical Center LLC
Independence, Missouri, United States
Status: Recruiting
Contact: Rakesh Gaur - 913-948-5588 - aroland@kccop.org
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States
Status: Recruiting
Contact: Rakesh Gaur - 913-948-5588 - aroland@kccop.org
North Kansas City Hospital
Kansas City, Missouri, United States
Status: Active, not recruiting
Research Medical Center
Kansas City, Missouri, United States
Status: Recruiting
Contact: Rakesh Gaur - 913-948-5588 - aroland@kccop.org
Saint Joseph Health Center
Kansas City, Missouri, United States
Status: Terminated
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Status: Terminated
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Status: Recruiting
Contact: Rakesh Gaur - 913-948-5588 - aroland@kccop.org
Truman Medical Center
Kansas City, Missouri, United States
Status: Terminated
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States
Status: Recruiting
Contact: Rakesh Gaur - 913-948-5588 - aroland@kccop.org
Liberty Hospital
Liberty, Missouri, United States
Status: Withdrawn
Liberty Radiation Oncology Center
Liberty, Missouri, United States
Status: Recruiting
Contact: Rakesh Gaur - 913-948-5588 - aroland@kccop.org
Phelps County Regional Medical Center
Rolla, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Status: Active, not recruiting
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Status: Recruiting
Contact: Rakesh Gaur - 913-948-5588 - aroland@kccop.org
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States
Status: Terminated
Mercy Hospital Saint Louis
Saint Louis, Missouri, United States
Status: Active, not recruiting
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Status: Terminated
CoxHealth South Hospital
Springfield, Missouri, United States
Status: Recruiting
Contact: Jay W. Carlson - 800-821-7532
Mercy Hospital Springfield
Springfield, Missouri, United States
Status: Active, not recruiting
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Status: Recruiting
Contact: Nicola M. Spirtos - 702-851-4672
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Status: Recruiting
Contact: Leslie R. DeMars - 800-639-6918 - cancer.research.nurse@dartmouth.edu
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States
Status: Active, not recruiting
Montefiore Medical Center-Einstein Campus
Bronx, New York, United States
Status: Active, not recruiting
Columbia University Medical Center
New York, New York, United States
Status: Recruiting
Contact: Jason D. Wright - 212-305-8615
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States
Status: Recruiting
Contact: John W. Byron - 910-715-2200
Southeast Cancer Consortium-Upstate NCORP
Winston-Salem, North Carolina, United States
Status: Recruiting
Contact: Robert F. Goodlett - 800-486-5941
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Status: Recruiting
Contact: Samuel S. Lentz - 336-713-6771
University of Cincinnati
Cincinnati, Ohio, United States
Status: Active, not recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Status: Recruiting
Contact: Robert S. Mannel - 405-271-4272 - julie-traylor@ouhsc.edu
Tulsa Cancer Institute
Tulsa, Oklahoma, United States
Status: Recruiting
Contact: Robert S. Mannel - 405-271-4272 - julie-traylor@ouhsc.edu
Geisinger Medical Center
Danville, Pennsylvania, United States
Status: Recruiting
Contact: Radhika P. Gogoi - 570-271-5251
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Status: Recruiting
Contact: Radhika P. Gogoi - 570-271-5251
Geisinger Medical Oncology at Evangelical Community Hospital
Lewisburg, Pennsylvania, United States
Status: Recruiting
Contact: Radhika P. Gogoi - 570-271-5251
Lewistown Hospital
Lewistown, Pennsylvania, United States
Status: Recruiting
Contact: Radhika P. Gogoi - 570-271-5251
Temple University Hospital
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Enrique Hernandez - 215-728-2983
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, United States
Status: Recruiting
Contact: Radhika P. Gogoi - 570-271-5251
Geisinger Medical Group
State College, Pennsylvania, United States
Status: Recruiting
Contact: Radhika P. Gogoi - 570-271-5251
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Status: Recruiting
Contact: Radhika P. Gogoi - 570-271-5251
Women and Infants Hospital
Providence, Rhode Island, United States
Status: Recruiting
Contact: Katina M. Robison - 401-274-1122
AnMed Health Cancer Center
Anderson, South Carolina, United States
Status: Recruiting
Contact: Robert F. Goodlett - 800-486-5941
Saint Francis Hospital
Greenville, South Carolina, United States
Status: Recruiting
Contact: Robert F. Goodlett - 800-486-5941
Spartanburg Medical Center
Spartanburg, South Carolina, United States
Status: Withdrawn
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Status: Withdrawn
University of Texas Medical Branch
Galveston, Texas, United States
Status: Active, not recruiting
Tohoku University School of Medicine
Sendai, Aoba-ku, Japan
Status: Recruiting
Contact: Nobuo Yaegashi - med-som@bureau.tohoku.ac.jp
Kure National Hospital
Kure, Hiroshima, Japan
Status: Recruiting
Contact: Takashi Sawasaki - (0823) 22-3111
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Status: Recruiting
Contact: Noriaki Sakuragi - hassi@med.hokudai.ac.jp
Hyogo Cancer Center
Akashi-city, Hyogo, Japan
Status: Recruiting
Contact: Shoji Nagao - 81-49-276-2028
Iwate Medical University School of Medicine
Morioka, Iwate, Japan
Status: Recruiting
Contact: Toru Sugiyama - 019-651-5111
Niigata University Medical and Dental Hospital
Niigata City, Niigata, Japan
Status: Recruiting
Contact: Takayuki Enomoto - 81-025-223-6161
University of the Ryukyus Hospital-Col Health Scnc
Nakagami-gun, Okinawa, Japan
Status: Recruiting
Contact: Yoichi Aoki - 888-823-5923 - ctsucontact@westat.com
Keio University
Shinjuku-ku, Tokyo, Japan
Status: Recruiting
Contact: Nobuyuki Susumu - 03 5363-3848
Hiroshima University Hospital
Hiroshima City, Japan
Status: Recruiting
Contact: Eiji Hirata - 82-424-6042
Kagoshima City Hospital
Kagoshima City, Kagoshima, Japan
Status: Recruiting
Contact: Masayuki Hatae - 011 81 099 224 2101
Shikoku Cancer Center
Matsuyama, Japan
Status: Recruiting
Contact: Takayoshi Nogawa - 089-999-1172
National Kyushu Cancer Center
Minami-ku, Japan
Status: Recruiting
Contact: Toshiaki Saito - 092-641-1151
Jikei University School of Medicine
Minato-ku, Tokyo, Japan
Status: Recruiting
Contact: Kyosuke Yamada - 03-3433-1111
Kinki University
Osaka, Osaka, Japan
Status: Recruiting
Contact: Masaki Mandai - 072-366-0221
Saitama Medical University International Medical Center
Saitama, Japan
Status: Recruiting
Contact: Keiichi Fujiwara - 81-49-276-2028
National Cancer Center Hospital
Tokyo, Japan
Status: Recruiting
Contact: Tomoyasu Kato - 81-3-3542-2511 - www-admin@ncc.go.jp
Tottori University
Tottori, Japan
Status: Active, not recruiting
Keimyung University-Dongsan Medical Center
Jung-Ku, Daegu, Korea, Republic of
Status: Recruiting
Contact: Soon-Do Cha - ho@dsmc.or.kr
National Cancer Center-Korea
Goyang-si, Gyeonggi-do, Korea, Republic of
Status: Active, not recruiting
Inha University
Jung-gu, Incheon, Korea, Republic of
Status: Active, not recruiting
Catholic University of Korea-Seoul Saint Mary's Hospital
Seoul, Korea, Korea, Republic of
Status: Recruiting
Contact: Keun H. Lee - 2258-5745-6
Seoul National University Bundang Hospital
Seongnam City, Kyeonggi-do, Korea, Republic of
Status: Recruiting
Contact: Kidong Kim - 011-82-760-2384
Asan Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Joo-Hyun Nam - 011-82-760-2384
Gangnam Severance Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Jae-Hoon Kim - clinical.trial@bms.com
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Active, not recruiting
Start Date
February 2009
Sponsors
Gynecologic Oncology Group
Source
Gynecologic Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page