Last updated on March 2019

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT00892866

Contact Investigators or Research Sites near you

Start Over

Hartford Hospital

Hartford, CT United States
  Connect »

Kootenai Medical Center

Coeur d'Alene, ID United States
  Connect »

Kootenai Cancer Center

Post Falls, ID United States
  Connect »

Kootenai Cancer Clinic

Sandpoint, ID United States
  Connect »

Elkhart Clinic

Elkhart, IN United States
  Connect »

Elkhart General Hospital

Elkhart, IN United States
  Connect »

IU Health La Porte Hospital

La Porte, IN United States
  Connect »

Memorial Hospital of South Bend

South Bend, IN United States
  Connect »

South Bend Clinic

South Bend, IN United States
  Connect »

Providence Medical Center

Kansas City, KS United States
  Connect »

Menorah Medical Center

Overland Park, KS United States
  Connect »

Saint Luke's South Hospital

Overland Park, KS United States
  Connect »

Woman's Hospital

Baton Rouge, LA United States
  Connect »

Baystate Medical Center

Springfield, MA United States
  Connect »

Marie Yeager Cancer Center

Saint Joseph, MI United States
  Connect »

Mayo Clinic

Rochester, MN United States
  Connect »

Centerpoint Medical Center LLC

Independence, MO United States
  Connect »

Truman Medical Center

Kansas City, MO United States
  Connect »

Saint Joseph Health Center

Kansas City, MO United States
  Connect »

North Kansas City Hospital

Kansas City, MO United States
  Connect »

Research Medical Center

Kansas City, MO United States
  Connect »

Saint Luke's East - Lee's Summit

Lee's Summit, MO United States
  Connect »

Heartland Regional Medical Center

Saint Joseph, MO United States
  Connect »

Saint Joseph Oncology Inc

Saint Joseph, MO United States
  Connect »

Mercy Hospital Saint Louis

Saint Louis, MO United States
  Connect »

Mercy Hospital Springfield

Springfield, MO United States
  Connect »

CoxHealth South Hospital

Springfield, MO United States
  Connect »

Saint Vincent Healthcare

Billings, MT United States
  Connect »

Bozeman Deaconess Hospital

Bozeman, MT United States
  Connect »

Great Falls Clinic

Great Falls, MT United States
  Connect »

Community Medical Hospital

Missoula, MT United States
  Connect »

University of Rochester

Rochester, NY United States
  Connect »

Adena Regional Medical Center

Chillicothe, OH United States
  Connect »

Mount Carmel East Hospital

Columbus, OH United States
  Connect »

Riverside Methodist Hospital

Columbus, OH United States
  Connect »

Grant Medical Center

Columbus, OH United States
  Connect »

Doctors Hospital

Columbus, OH United States
  Connect »

Delaware Radiation Oncology

Delaware, OH United States
  Connect »

Grady Memorial Hospital

Delaware, OH United States
  Connect »

Fairfield Medical Center

Lancaster, OH United States
  Connect »

OhioHealth Mansfield Hospital

Mansfield, OH United States
  Connect »

Marietta Memorial Hospital

Marietta, OH United States
  Connect »

Knox Community Hospital

Mount Vernon, OH United States
  Connect »

Licking Memorial Hospital

Newark, OH United States
  Connect »

Newark Radiation Oncology

Newark, OH United States
  Connect »

Southern Ohio Medical Center

Portsmouth, OH United States
  Connect »

Saint Ann's Hospital

Westerville, OH United States
  Connect »

Geisinger Medical Center

Danville, PA United States
  Connect »

Lewistown Hospital

Lewistown, PA United States
  Connect »

Temple University Hospital

Philadelphia, PA United States
  Connect »

Community Medical Center

Scranton, PA United States
  Connect »

Geisinger Medical Group

State College, PA United States
  Connect »

Women and Infants Hospital

Providence, RI United States
  Connect »

AnMed Health Cancer Center

Anderson, SC United States
  Connect »

Saint Francis Hospital

Greenville, SC United States
  Connect »

Spartanburg Medical Center

Spartanburg, SC United States
  Connect »

Avera Cancer Institute

Sioux Falls, SD United States
  Connect »

Billings Clinic-Cody

Cody, WY United States
  Connect »

Welch Cancer Center

Sheridan, WY United States
  Connect »

Keio University

Shinjuku-ku, Japan
  Connect »

Kindai University

Osaka, Osaka, Japan
  Connect »

National Cancer Center-Korea

Goyang-si, Korea, Republic of
  Connect »

Gachon University Gil Hospital

Incheon, Korea, Republic of
  Connect »

Gangnam Severance Hospital

Seoul, Korea, Republic of
  Connect »

Asan Medical Center

Seoul, Korea, Republic of
  Connect »

Shawnee Mission Medical Center-KCCC

Shawnee Mission, KS United States
  Connect »

Lakeland Hospital Niles

Niles, MI United States
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.