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Member Research & Reports

Member Research & Reports

UNC Study Finds Urine Sampling Can Be Effective Screening Tool for High-risk HPV

Researchers from the University of North Carolina at Chapel Hill have found that urine testing for high-risk human papillomavirus (HR-HPV) detection could provide a non-invasive, simple method for cervical cancer screening.

[Photo: Dr. Jennifer Smith]

Members of the team, including principal investigator Dr. Jennifer S. Smith, associate professor of epidemiology at the UNC Gillings School of Global Public Health, conducted a study in which they examined urine samples obtained from 37 women with suspected cervical disease attending the Gynecologic Oncology clinic at UNC Hospitals.

Samples taken from “first void” urine at home, as well as initial-stream and mid-stream samples taken at the clinic later in the day, were assayed using an HPV DNA test produced by Trovagene Inc., based in San Diego. All participants underwent colposcopy, a procedure using microscopic imaging and cervical biopsies, to confirm the presence of cancer or precancerous changes in the cervix.

The study, among the first to compare methodologies for collection and processing of urine for high-risk (HR) HPV detection, found similar detection of HR HPV in first void and initial-stream urine and found that the assay was highly sensitive for detection of cervical intraepithelial neoplasia, grade 2 or more severe (CIN2+).

With adequate screening and treatment, invasive cervical cancer is almost entirely preventable. However, women in many low- and middle-income countries rarely have access to screening, and many women in wealthier countries are not screened according to guidelines. In the United States, about 56 percent of invasive cervical cancer is due to insufficient screening. In 2012, 11.4 percent of U.S. women ages 21 years to 65 years reported no screening within the preceding five years.

Current cervical cancer screening strategies in the U.S. include Pap testing alone every three years or a combined Pap test and test for HR-HPV every five years. Currently, both methods require pelvic examination by trained medical personnel. Urine collection to detect HR-HPV could provide an especially simple, non-invasive screening method for improving access to screening in areas where women have little access to medical care or where resources are limited.

“HPV testing on urine is a promising diagnostic method that could be more accessible and more easily scalable to increase cervical cancer screening and reduce mortality among underscreened women in the U.S. and globally,” principal investigator Dr. Smith said. “Our findings from this small sample of high-risk women will have to be confirmed with larger studies in the general population.”

In addition to Dr. Smith and first author Dr. Virginia Senkomago, research affiliate in epidemiology at the UNC Gillings School, study authors include project manager Ms. Andrea Des Marais, Dr. Lisa Rahangdale, associate professor of Women’s Primary Healthcare at the UNC School of Medicine and senior medical director for OB-GYN Ambulatory at UNC Hospitals; and Dr. Cecile Rose T. Vibat, and Dr. Mark G. Erlander, of Trovagene Inc.

Drs. Smith and Rahangdale also are members of UNC Lineberger Comprehensive Cancer Center.

The study, “Comparison of Urine Specimen Collection Times and Testing Fractions for the Detection of High-Risk Human Papillomavirus and High-Grade Cervical Precancer,” was published online November 5, 2015 in the Journal of Clinical Virology.

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