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NCT00892866 Clinical Trial

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

Human Papillomavirus Infection Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00892866
Other study ID # GOG-0237
Secondary ID NCI-2009-01103CD
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 13, 2009
Est. completion date May 31, 2025

Study information
Verified date May 2024
Source GOG Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 877
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Cytology Specimen Collection Procedure
Correlative studies
• Laboratory Biomarker Analysis
Correlative studies

Locations
Country Name City State
Japan Hyogo Cancer Center Akashi-city Hyogo
Japan Hiroshima University Hospital Hiroshima City
Japan Kagoshima City Hospital Kagoshima City Kagoshima
Japan Kure National Hospital Kure Hiroshima
Japan Shikoku Cancer Center Matsuyama
Japan National Kyushu Cancer Center Minami-ku
Japan Jikei University School of Medicine Minato-ku, Tokyo
Japan University of the Ryukyus Hospital-Col Health Scnc Nakagami-gun Okinawa
Japan Niigata University Medical and Dental Hospital Niigata City Niigata
Japan Kindai University Osaka
Japan Saitama Medical University International Medical Center Saitama
Japan Hokkaido University Hospital Sapporo Hokkaido
Japan Tohoku University School of Medicine Sendai Aoba-ku
Japan Keio University Shinjuku-ku Tokyo
Japan Iwate Medical University Hospital Shiwa-gun Iwate
Japan National Cancer Center Hospital Tokyo
Japan Tottori University Tottori
Korea, Republic of Keimyung University-Dongsan Medical Center Dalseo-gu Daegu
Korea, Republic of National Cancer Center-Korea Goyang-si Gyeonggi-do
Korea, Republic of Gachon University Gil Hospital Incheon
Korea, Republic of Inha University Jung-gu Incheon
Korea, Republic of Seoul National University Bundang Hospital Seongnam City Kyeonggi-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Catholic University of Korea-Seoul Saint Mary's Hospital Seoul Korea
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Kyung Hee University Hospital at Gangdong Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Yonsei University Health System-Severance Hospital Seoul
United States Community Hospital of Anaconda Anaconda Montana
United States AnMed Health Cancer Center Anderson South Carolina
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Woman's Hospital Baton Rouge Louisiana
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Billings Clinic Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Bozeman Deaconess Hospital Bozeman Montana
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Adena Regional Medical Center Chillicothe Ohio
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Big Horn Basin Cancer Center Cody Wyoming
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Geisinger Medical Center Danville Pennsylvania
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 Elkhart Clinic Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Walter Knox Memorial Hospital Emmett Idaho
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Central Ohio Breast and Endocrine Surgery Gahanna Ohio
United States University of Texas Medical Branch Galveston Texas
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Saint Francis Hospital Greenville South Carolina
United States Hartford Hospital Hartford Connecticut
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Memorial Hermann Texas Medical Center Houston Texas
United States Centerpoint Medical Center LLC Independence Missouri
United States Kalispell Regional Medical Center Kalispell Montana
United States Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Providence Medical Center Kansas City Kansas
United States Research Medical Center Kansas City Missouri
United States Saint Joseph Health Center Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States Truman Medical Centers Kansas City Missouri
United States Community Howard Regional Health Kokomo Indiana
United States UC San Diego Moores Cancer Center La Jolla California
United States IU Health La Porte Hospital La Porte Indiana
United States Fairfield Medical Center Lancaster Ohio
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States UTMB Cancer Center at Victory Lakes League City Texas
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas
United States Minimally Invasive Surgery Hospital Lenexa Kansas
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Lewistown Hospital Lewistown Pennsylvania
United States Liberty Radiation Oncology Center Liberty Missouri
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Marietta Memorial Hospital Marietta Ohio
United States OhioHealth Marion General Hospital Marion Ohio
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Community Medical Hospital Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States Saint Alphonsus Medical Center-Nampa Nampa Idaho
United States Norris Cotton Cancer Center-Nashua Nashua New Hampshire
United States The Hospital of Central Connecticut New Britain Connecticut
United States Saint Peter's University Hospital New Brunswick New Jersey
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Licking Memorial Hospital Newark Ohio
United States Newark Radiation Oncology Newark Ohio
United States Rutgers New Jersey Medical School Newark New Jersey
United States Lakeland Hospital Niles Niles Michigan
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Saint Joseph Hospital - Orange Orange California
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States Temple University Hospital Philadelphia Pennsylvania
United States FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States Maine Medical Center-Bramhall Campus Portland Maine
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Women and Infants Hospital Providence Rhode Island
United States Mayo Clinic in Rochester Rochester Minnesota
United States University of Rochester Rochester New York
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Marie Yeager Cancer Center Saint Joseph Michigan
United States Saint Joseph Oncology Inc Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Maine Medical Center- Scarborough Campus Scarborough Maine
United States Community Medical Center Scranton Pennsylvania
United States Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania
United States Advent Health - Shawnee Mission Medical Center Shawnee Mission Kansas
United States Welch Cancer Center Sheridan Wyoming
United States Avera Cancer Institute Sioux Falls South Dakota
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 Spartanburg Medical Center Spartanburg South Carolina
United States Baystate Medical Center Springfield Massachusetts
United States CoxHealth South Hospital Springfield Missouri
United States Mercy Hospital Springfield Springfield Missouri
United States Geisinger Medical Group State College Pennsylvania
United States Olive View-University of California Los Angeles Medical Center Sylmar California
United States Banner University Medical Center - Tucson Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Saint Ann's Hospital Westerville Ohio
United States Michiana Hematology Oncology PC-Westville Westville Indiana
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (2)
Lead Sponsor Collaborator
GOG Foundation National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Japan,  Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other Biomarker expression, loss of heterozygosity (LOH), chromosome gains, and chromosome losses in tissue from the highest grade or most abnormal lesions in women with AGC Exploratory analyses of genomic alterations, including LOH as well as chromosome gains and chromosome losses will be performed to identify genomic alterations associated with cervical dysplasia/neoplasia. Baseline
Other CA-IX expression, combined p16 and Ki67 expression, and MCM2 expression in LBC specimens Will be used to see which subset of markers will provide the higher and sensitivity in the diagnosis of cervical AIS. Baseline
Primary Biomarker expression in patients from North America CA-IX, p16, Ki-67, and MCM2 expression in LBC specimens is measured via IHC. A logistic regression and receiver operating characteristic (ROC)-type analysis will be performed. Baseline
Primary Biomarker expression in patients from Japan CA-IX, p16, Ki-67, and MCM2 expression in LBC specimens is measured via IHC. A logistic regression and ROC-type analysis will be performed. Baseline
Primary Biomarker expression in patients from Korea CA-IX, p16, Ki-67, and MCM2 expression in LBC specimens is measured via IHC. A logistic regression and ROC-type analysis will be performed. Baseline
Secondary Effect of patient age on the accuracy of diagnosis based on CA-IX, HPV, p16, Ki-67, and/or MCM2 expression in the North American population Logistic regression analyses will be performed to assess the effect of age and country on sensitivity, specificity, false positive rate (FPR), and complement negative predictive value (NPVC.). For each country and at each age, an upper 95% confidence limit will be calculated for the NPVC. Baseline
Secondary Effect of patient age on the accuracy of diagnosis based on CA-IX, HPV, p16, Ki-67, and/or MCM2 expression in the Korean and Japanese populations Logistic regression analyses will be performed to assess the effect of age and country on sensitivity, specificity, FPR, and NPVC. For each country and at each age, an upper 95% confidence limit will be calculated for the NPVC. Baseline
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