Editors' ChoiceResults of a randomized trial on the management of cytology interpretations of atypical squamous cells of undetermined significance☆,☆☆,★
Section snippets
Overview
ALTS was a randomized clinical trial comparing three strategies for women with ASCUS and LSIL separately: immediate colposcopy, HPV triage, and conservative management, based on a program of repeat cytology.6 All women, regardless of randomization assignment and initial management during enrollment, were scheduled for follow-up with cytology at 6-month intervals for 2 years. We achieved very high retention rates and adherence to protocols, which permitted thorough analyses of the performance of
Results
ALTS enrolled 3488 eligible women with a community Pap smear interpretation of ASCUS, and randomly assigned 1163 to the IC arm, 1161 to HPV triage, and 1164 to the CM arm (Figure).
Comment
For women with ASCUS cytology interpretations, the ALTS data demonstrate that HPV triage is at least as sensitive as immediate colposcopy in the detection of underlying CIN grade 3, while nearly halving the number of women referred for colposcopy. Repeat cytology with colposcopic referral at an ASCUS threshold is also sensitive in detecting CIN grade 3 but requires repeated visits and leads to significantly more colposcopic examinations than does a single HPV test. Although the final
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2024, Journal of Lower Genital Tract DiseasePerformance of p16/Ki67 Immunostaining for Triage of Elderly Women with Atypical Squamous Cells of Undetermined Significance
2023, Journal of Clinical Medicine
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Supported by the National Cancer Institute, National Institutes of Health Department of Health and Human Services contracts No. CN-55153, CN-55154, CN-55155, CN-55156, CN-55157, CN-55158, CN-55159, and CN-55105. Some of the equipment and supplies used in this study were donated or provided at reduced cost by Digene Corporation, Gaithersburg, Md; Cytyc Corporation, Boxborough, Mass; National Testing Laboratories, Fenton, Mo; Denvu, Tucson, Ariz; and TriPath Imaging, Inc, Burlington, NC.
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Reprint requests: Diane Solomon, MD, Breast and Gynecologic Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, NIH, DHHS, Executive Plaza North, Room 2123, Rockville, MD 20852. E-mail: [email protected]
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*A complete list of ALTS investigators begins on page 1411.