Key Programs

The ASCUS/LSIL Triage Study for Cervical Cancer (ALTS)

ALTS Trial Design and Study Centers

Trial Design

Approximately 55 million Pap smears are performed each year in the United States. The vast majority of results are negative (no abnormality identified) but about 5% to 8% are reported as abnormal. Most low-grade changes regress spontaneously; only a minority of such lesions would progress to a cancer precursor without treatment. However, currently there is no way to determine morphologically which patients are at risk of progression. Therefore, both high- and low-grade lesions are often managed with colposcopy and directed biopsy. Determining alternative management strategies could yield important potential benefits including fewer medical complications from overtreatment, reduced patient anxiety associated with referral for cytologic abnormalities, as well as cost savings.

Epidemiologic, virologic and molecular studies have clearly demonstrated that human papillomavirus (HPV) is the central cause of cervical cancer. The motivation for the ALTS trial was to use the information we have gained about the role of HPV to design better treatment and prevention strategies to reduce the burden of cervical cancer and its precursors.

ALTS consisted of three management strategies: (1) immediate colposcopy of all women; (2) repeat cytology with colposcopy only if the results show a high grade lesion; and (3) HPV testing and repeat cytology in combination, with referral to colposcopy if either the HPV test is positive or the cytology shows a high grade lesion. Four Clinical Centers - University of Alabama, Birmingham AL; Magee-Womens Hospital, Pittsburgh PA; University of Oklahoma, Oklahoma City OK; and University of Washington, Seattle WA - enrolled approximately 5,000 women with a recent diagnosis of ASCUS or LSIL. Participants were followed at six month intervals for a total of 2 years. ALTS is comparing the efficacy and cost-effectiveness of the different strategies in the early detection of high-grade lesions.

The trial design and methods are described in: Schiffman, M. and Adrianza, E., ASCUS-LSIL Triage Study: Design, Methods and Characteristics of Trial Participants, Acta Cytologica, Sep-Oct 2000:44(5):726-42.

Study Centers

Study centers that participated in ALTS were:

• University of Alabama at Birmingham - Investigators: Edward E. Partridge, M.D., Professor and Vice Chairman of the Department of Obstetrics; Larry Clinton Kilgore, M.D., Associate Professor in the UAB Division of Gynecologic Oncology; Ronald David Alvarez, M.D., Associate Professor in the UAB Division of Gynecologic Oncology; Mack Nathaniel Barnes, III, M.D., Assistant Professor in the Division of Gynecologic Oncology; Study Manager: Shirley Hester, MSN CRNP
• University of Oklahoma - Investigators: Joan L. Walker, M.D., Associate Professor and Chief of the Gynecologic Oncology Section; Gary A. Johnson, M.D.
• Magee-Womens Hospital of the University of Pittsburgh Medical Center Health System - Investigators: Richard S. Guido, M.D., Assistant Professor in the Department of Obstetrics and Gynecology; Kathleen McIntyre-Seltman, M.D., Associate Professor in the Department of Obstetrics and Gynecology; Study Manager: Judy Gruss, RN
• University of Washington at Seattle - Investigators: Nancy Kiviat, M.D., Professor of Pathology; Laura Koutsky, Ph.D., Associate Professor of Epidemiology at the University of Washington; Study Manager: Joanna Haug, MPH