M.D. Anderson Cancer Center
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.
This is a prospective, single-arm community trial involving 678 women aged 25 to 49 years for evaluation of positive cervical cancer screening tests (abnormal cytology, VIA+ and/or HPV+ test). Eligible women will be offered enrollment at the time of their consultation for a follow-up of their abnormal cervical cancer screening test. Participating centers include: 1) Mavalane Hospital and Health Center and 2) José Macamo General Hospital (José Macamo), 3) Maputo Central Hospital. After providing the informed consent, the participant will answer a short questionnaire that will include demograph…
Inclusion Criteria: 1. 25 - 49 year old women 2. Women with a positive cervical cancer screening test (abnormal cytology, positive VIA and/or positive HPV test) 3. Women with intact cervix 4. Women who are not pregnant and with a negative pregnancy test (within 14 days from the date of enrollment) ) and not currently breastfeeding 5. Willing and capable of providing informed consent Exclusion Criteria: 1. Women under 25 or over 49 years old 2. Women who have undergone a total hysterectomy (with removal of the cervix) 3. Women who are pregnant or breastfeeding
Women referred for colposcopy due to abnormal cervical screening will be recruited into the experimental group of the study. Imaging of study participants will take place during the colposcopy examination.
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