ALTS intends to determine the optimal management of mildly abnormal Pap smears (encompassing LSIL and ASCUS)in women. Specifically, the trial will evaluate three possible management strategies: (1) Immediate colposcopy, the most common management option currently, and the most invasive and expensive; (2) HPV triage, in which participants will be typed for the HPV virus via Hybrid Capture Microtiter testing and triaged to colposcopy based upon the identification of a high-risk (oncogenic) viral type; and (3) conservative management, in which participants will be followed by cytology results at 6 month intervals, and triaged to colposcopy in the event of high-grade cytologic diagnosis. All women enrolled into ALTS will be followed, after the initial visit, at 6 month intervals with cytologic testing for 2 years. Collection of cervical cells, masked HPV tests, and bloodwork and cervical secretions obtained through an immunological component will provide information about both the natural history of mild cervical dysplasia as well as differences among management arms, if they exist. Treatment acceptability and quality of life data will be collected as well.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000056-39
Application #
6409124
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1978-12-01
Project End
2003-11-30
Budget Start
Budget End
Support Year
39
Fiscal Year
2000
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Type
DUNS #
053785812
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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