1,002
Participants
Start Date
August 2, 2023
Primary Completion Date
July 31, 2026
Study Completion Date
March 31, 2027
Xpert HPV
The Cepheid Xpert HPV Assay (Xpert HPV) is a qualitative, real-time polymerase chain reaction (PCR) assay for the detection of hrHPV DNA. The assay is formatted in a single-use, Xpert HPV test cartridge and is run on the Cepheid Xpert® System, a multi-analyte, random access, molecular-diagnostic platform ranging in capacity from 1 to 80 test processing modules. Importantly, a single hrHPV DNA test can be completed in one hour, permitting same-day screening and diagnosis (e.g. colposcopy) or treatment (e.g. cryotherapy), reducing the potential for loss to follow-up in lower-resource settings. It uses liquid-based cytologic media and yields five separate results or channels: HPV 16, HPV 18/45, HPV 31/33/35/52/58, HPV 51/59, HPV 39/68/56/66 all with a corresponding cycle threshold.
QIAsure Methylation Test
The Qiagen QIAsure assay is a multiplex real-time PCR test that amplifies the methylated promoter regions of the tumor suppressor genes, FAM19A4 and has-mir124-2, as well as a methylation-unspecific fragment of the ACTB reference gene. Hypermethylation of the host genes FAM19A4 and has-mir124-2 has been shown to detect high-grade cervical lesions and cancer.
National Institute of Public Health, Mexico, Cuernavaca
University of São Paulo, São Paulo
National Cancer Institute (NCI)
NIH
H. Lee Moffitt Cancer Center and Research Institute
OTHER
University of Sao Paulo
OTHER
Mexican National Institute of Public Health
OTHER_GOV
University of California, San Diego
OTHER
Instituto Nacional de Salud Publica, Mexico
OTHER
Weill Medical College of Cornell University
OTHER