ASCUS-LSIL Triage Study. Design, methods and characteristics of trial participants.

OBJECTIVE

To describe the design and methods of the ASCUS-LSIL Triage Study (ALTS), a multicenter, randomized clinical trial designed to evaluate three alternative methods of managing low grade (LSIL) and equivocal (ASCUS) cervical cytologic diagnoses.

STUDY DESIGN

Nonpregnant women, 18+ years old, with ASCUS or LSIL, no prior hysterectomy or ablative therapy to the cervix, were referred to one of four clinical centers around the United States. Eligible and consenting participants were administered a risk-factor questionnaire and underwent a pelvic examination, collection of cervical specimens for liquid-based cytology and human papillomavirus (HPV) testing and Cervicography (National Testing Laboratories, Fenton, Missouri, U.S.A.). Patients were randomized to one of three arms: (1) immediate referral for colposcopy at enrollment, (2) follow-up with cytology only, and (3) use of HPV DNA testing to triage to colposcopy. All women are followed every six months for two years with pelvic examinations, cytologic and masked HPV testing, and masked Cervicography. Digital cervical images and cytology and histology slides are externally reviewed to maximize patient safety.

RESULTS

We enrolled and randomized 3,488 eligible women with ASCUS and 1,572 women with LSIL.

CONCLUSION

The successful enrollment, randomization and high rates of follow-up are encouraging. The study will help clarify the optimal strategies for managing low grade cervical abnormalities.