Assessment of New Technologies for the Screening and Diagnosis of Cervical Cancer in Mozambique, A Study to be Conducted in Maputo Central Hospital, Mavalane and Jose Macamo General Hospitals and Mavalane Health Center
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 49
Healthy Volunteers: f
View:
• 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
• Willing and capable of providing informed consent
Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Other Locations
Mozambique
José Macamo General Hospital and Health Center
RECRUITING
Maputo
Maputo Central Hospital
RECRUITING
Maputo
Mavalane Hospital and Health Center
RECRUITING
Maputo
Contact Information
Primary
Mila Salcedo, MD, PhD
mpsalcedo@mdanderson.org
(832) 696-6794
Time Frame
Start Date: 2021-03-24
Estimated Completion Date: 2028-03-30
Participants
Target number of participants: 678
Treatments
Experimental: Multi-Modal Optical Imaging
Multi-modal imaging (mobile colposcopy and high resolution imaging) of study participants will be performed during the colposcopy examination. Cervical biopsies will be performed using biopsy forceps per standard protocols.
Authors
Andrea Neves, Arlete Mariano, Ricardina Rangeiro
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: William Marsh Rice University, Eduardo Mondlane University