Spots Global Cancer Trial Database for CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells
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Trial Identification
Brief Title: CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells
Official 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)
Study ID: NCT00892866
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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 Saint Louis, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, 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
Montefiore Medical Center-Einstein Campus, Bronx, New York, 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
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-city, Hyogo, Japan
Iwate Medical University Hospital, Shiwa-gun, Iwate, Japan
Kagoshima City Hospital, Kagoshima City, Kagoshima, Japan
Niigata University Medical and Dental Hospital, Niigata City, Niigata, Japan
University of the Ryukyus Hospital-Col Health Scnc, Nakagami-gun, Okinawa, Japan
Keio University, Shinjuku-ku, Tokyo, Japan
Hiroshima University Hospital, Hiroshima City, , Japan
Shikoku Cancer Center, Matsuyama, , Japan
National Kyushu Cancer Center, Minami-ku, , 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, Korea, Republic of
National Cancer Center-Korea, Goyang-si, Gyeonggi-do, Korea, Republic of
Inha University, Jung-gu, Incheon, Korea, Republic of
Catholic University of Korea-Seoul Saint Mary's Hospital, Seoul, Korea, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam City, Kyeonggi-do, Korea, Republic of
Gachon University Gil Hospital, Incheon, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Gangnam Severance Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Yonsei University Health System-Severance Hospital, Seoul, , Korea, Republic of
Kyung Hee University Hospital at Gangdong, Seoul, , Korea, Republic of
Contact Details
Name: Shu-Yuan liao
Affiliation: Gynecologic Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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