About this trial
The study aims to compare the accuracy of the lateral flow test to detect HPV at the POC with commercially available HPV test and to determine the diagnostic accuracy and reliability of a multimodal optical imaging system to detect cervical dysplasia, with the gold reference standard of histopathology.
Eligibility criteria
Qualifiers
25 - 49 year old women
Women with a positive cervical cancer screening test (abnormal cytology, positive VIA and/or positive HPV test)
Women with intact cervix
Women who are not pregnant and with a negative pregnancy test (within 14 days from the date of enrollment) ) and not currently breastfeeding
Disqualifiers
Women under 25 or over 49 years old
Women who have undergone a total hysterectomy (with removal of the cervix)
Women who are pregnant or breastfeeding
Trial design
Treatments tested in this trial
- Multimodal optical imaging
Treatment groups
Sponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Eduardo Mondlane University
Collaborator
William Marsh Rice University
Collaborator