Researchers at Emory University are participating in a large national study to evaluate an investigational test used to detect high-risk human papillomavirus (HPV), which in some cases can lead to a woman developing cervical cancer.
The investigational test would be performed in conjunction with a woman's annual Pap test in an effort to find a better method of detecting cervical disease, either pre-cancerous or cancerous.
"This is a second generation of testing for cervical cancer and cervical cancer precursors," says Kevin Ault, MD, associate professor in the Department of Gynecology and Obstetrics, Emory University School of Medicine and principal investigator of the study at Emory. "We've been using the standard Pap test since the mid-1950's, and while this test has drastically reduced the number of deaths from cervical cancer, it does report false negatives." (A false negative means there is actually a disease or other condition, but the results come back as negative).
"A newer, approved HPV test on the market tends to yield false positives and is more expensive than Pap testing," says Ault. "So, we need a better standard in testing for HPV and cervical cancer.
Human papillomaviruses are a group of more than 100 related viruses. They are called papillomaviruses because certain types may cause warts, or papillomas, which are benign (non-cancerous) tumors. Some types of HPV are associated with certain types of cancer. These are called high-risk or carcinogenic HPVs.
The new automated APTIMA HPV Assay test studied at Emory is designed to detect 14 high-risk HPV types that are associated with or progress towards cervical cancer.
Diagnosing HPV is useful in two situations that women commonly face. HPV testing may be useful in women with mildly abnormal Pap smears. Also, HPV testing may be a useful test in detecting a precancerous problem in women older than 30. Both of these problems will be studied in this clinical trial.
"We hope this research study will help us find a better and more effective test for detecting high-risk HPV infections," says Ault. "We've previously identified a vaccine to protect young women against two major strains of HPV. Now we must work to find a better detection device."
Some 7,000 women are expected to enroll in the study nationwide. Gen-Probe, Incorporated, the maker of the assay test, is funding this study.
To enroll in this HPV investigational test clinical trial or to find out more about participation, please call Shara Karlebach, study coordinator, at 404-778-4169.