Trial Information

Low-Cost Molecular Cervical Cancer Screening Study

Low-cost, molecular human papillomavirus (HPV) testing may offer a more robust alternative
to Pap smears and visual inspection with acetic acid (VIA) for cervical cancer screening of
underserved women. Two low-cost molecular tests for human papillomavirus (HPV) have been
developed: 1) AVantage HPV E6 Test (Arbor Vita Corporation, Sunnyvale, CA, USA) ( HPV E6
Test ) detects E6 oncoproteins from HPV16, 18, and 45 and 2) careHPV (Qiagen, Gaithersburg,
MD, USA) detects the DNA for a pool of 14 carcinogenic HPV genotypes. The HPV E6 Test will
be ready for the first clinical evaluations in 2010. The HPV E6 Test works like an ELISA in
strip format such that it takes less than two hours to run and may provide point-of-care
(diagnostic testing at or near the site of patient care) testing. careHPV, a batch HPV DNA
test that takes 2.5 hours to perform, has already been developed and is currently being used
in demonstration projects. The results to date for careHPV are promising. As our primary
objective, we wish to evaluate both tests, and to evaluate the best low-cost triage
strategies for careHPV-positive results in areas of high prevalence of carcinogenic HPV DNA.
A study of 7,500 women, ages 25-65 years, identified from an age- and region-stratified
sample of women living in rural China will be conducted. All women will be screened at
enrollment, and a high-risk subgroup at the one-year follow-up, by the following tests: HPV
E6 Test, careHPV, and visual inspection with acetic acid (VIA). Women will also be screened
at enrollment, and a high-risk subgroup at the one-year follow-up, using the digene HC2 HPV
DNA Test TM ( HC2 ) (formerly known as Hybrid Capture 2)(Qiagen), the first U.S. Food and
Drug Administration-approved HPV test and the gold standard for clinical HPV testing. At
both time points, all screen-positive women will be evaluated by colposcopy using a rigorous
diagnostic protocol. A random sample of screen negatives will undergo colposcopy but will
only undergo biopsies if there is visual evidence of cervical epithelial abnormalities.
careHPV-positive specimens will be tested for most carcinogenic HPV genotypes, HPV16, HPV18,
and HPV45 using careHPV16/18/45. This triage test utilizes the same test platform as
careHPV but screens only for those 3 carcinogenic HPV genotypes. The primary goals are 1) to
evaluate the clinical performance of careHPV, the HPV E6 Test, and VIA for detection of
cervical precancer and cancer and 2) to determine the positive predictive values of VIA, the
HPV E6 Test, and HPV16/18/45 detection by careHPV16/18/45 for cervical precancer and cancer
among careHPV-positive women.