Rice Technologies for Cervical Cancer Screening and Diagnosis
ConditionCervical Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-49
SponsorM.D. Anderson Cancer Center
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Multimodal optical imaging
DeviceWomen 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.
Treatment groups
678 Participants
are divided into 1 treatment groupGroup A: Multi-Modal Optical ImagingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Development of multimodal optical imaging system
Image data will be used as a training set to develop and refine image analysis algorithms. Multimodal Mobile Colposcope will be compared with colposcopic impression considering clinical performance (sensitivity, specificity, positive and negative predictive values, and area under the Receiver Operating Characteristic (ROC) curve)
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Eduardo Mondlane University
Collaborator
William Marsh Rice University
Collaborator
Source ClinicalTrials.gov