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Low-Cost Molecular Cervical Cancer Screening Study

25 Years
65 Years
Not Enrolling
DNA Probes, E6 Protein, Uterine Cervical Neoplasms, HPV

Thank you

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.

Inclusion Criteria


1. have not been previously diagnosed with cervical cancer

2. have a cervix

3. are not pregnant

4. are physically able to undergo routine cervical cancer screening 5) are able to
provide informed consent

- We will not exclude women if they have had previous cervical cancer screening because
we assume that even if a few women have been screened for cervical cancer, the
quality of cytology screening was very poor.


1) are not married AND report never having had sexual intercourse 2) have had a total

3) have a history of cervical cancer

4) are physically or mentally unable to undergo routine cervical cancer screening or
unable to provide informed consent.

5) are pregnant or have been pregnant in the last month

-Women who are currently menstruating at the time of enrollment will be deferred from
participating, and will become eligible to participate 7-14 days after menstruation has
ended. The menstruating women will be advised to return for the screening 7 to 14 days
after their menstrual period has concluded.

Type of Study:


Study Design:

Time Perspective: Prospective


United States: Federal Government

Study ID:




Start Date:

October 2010

Completion Date:

December 2010

Related Keywords:

  • DNA Probes
  • E6 Protein
  • Uterine Cervical Neoplasms
  • HPV
  • Cervical Cancer
  • Human Papilloma Virus (HPV)
  • Cervical Intraepithelial Neoplasia (CIN)
  • Neoplasms
  • Uterine Cervical Neoplasms



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