| Year: 2007 | 
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| LHNCBC-2007-081 |
| Visual Appearance of the Uterine Cervix: Correlation with Human Papillomavirus Detection and Type |
| Jeronimo J, Massad LS, Schiffman M for the NIH-ASCCP Research Group |
| Am J Obstet Gynecol 2007; 197:47.e1-47.e8. |
| This was a substudy of the ASCUS (atypical squamous cells of undetermined significance)- LSIL (low-grade squamous intraepithelial lesion) Triage study (ALTS). The design of ALTS and characteristics of the population have been described previously. The study was approved by the National Cancer Institute and local institutional review boards. Briefly, 5060 women were enrolled because they had received a community-based cytologic diagnosis of ASCUS (n = 3488) or LSIL (n = 1572). They were assigned randomly to 1 of 3 treatment strategies (immediate colposcopy, triage based on HPV results and liquid-based cytologic results, or triage based on cytologic results only). The study took place in 4 clinical settings: Magee-Women's Hospital of the University of Pittsburgh Medical Center Health System (Pittsburgh, PA), the University of Oklahoma (Oklahoma City, OK), the University of Alabama (Birmingham, AL), and the University of Washington (Seattle, WA). Written informed consent was obtained from each woman. Using a broom sampler, we collected cervical samples into PreservCyt (Cytyc Corporation, Boxborough, MA) for liquid-based cytologic results (ThinPrep; Cytyc Corporation) and Hybrid Capture 2 (Digene Corporation, Gaithersburg, MD) HPV detection of a pool of 13+ carcinogenic HPVs. For the HPV typing that is reported in this substudy, we also collected a Dacron-swab specimen placed into Specimen Transport Medium (Digene Corporation). Finally, the cervix was washed with 5% acetic acid and 2 cervigrams (National Testing Laboratories, Fenton, MO) were taken. Women were followed for 2 years with an aggressive exit strategy to maximize safety (ie, detection of cervical intraepithelial neoplasia 2+ [CIN2+] and especially CIN3+). In ALTS, the demonstrated imperfect sensitivity of the first colposcopy to detect many cases of CIN3 that, in retrospect, were present at enrollment led the investigators to classify final disease status as CIN3+, CIN2, CIN1, or less than CIN1 on the basis of the worst histologic evidence that was found during the trial. The final diagnosis during ALTS, rather than the provisional diagnosis at the time of colposcopy, was used for these analyses. |
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