Low-cost Imaging Technology for Global Prevention of Cervical Cancer
ConditionCervical Intraepithelial Neoplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25+
SponsorBarretos Cancer Hospital
About this trial
Cervical cancer remains the first or second leading cause of cancer death among women in many low-and middle-income countries. Cervical cancer prevention programs in low-resource settings are hampered by a lack of personnel with appropriate clinical expertise, lack of pathology services, and lack of associated infrastructure. There is an urgent need for appropriate diagnostic tools to enable accurate screening and diagnosis in low-resource settings. The purpose of this study is to develop and validate a low-cost Multimodal Mobile Colposcope (MMC) for global cervical cancer prevention programs. This new device will combine the imaging capabilities of a mobile colposcope with the microscopic imaging capabilities of a fiber-optic confocal imaging probe.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women >25 years of age;
Women undergoing colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia;
Women of childbearing potential must have a negative urine or blood pregnancy test;
Ability to understand and willingness to provide informed consent by signing specific Informed Consent Document.
Disqualifiers
Women under 25 years of age;
Women who have undergone hysterectomy with removal of the cervix;
Women with known allergy to proflavine or acriflavine;
Women who are pregnant or nursing at the time of enrollment;
Trial design
Design model
Single group
Treatments tested in this trial
Multimodal Mobile Colposcope (MMC)
DeviceWomen referred for colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia will be recruited into the experimental group of the study. Imaging of study participants will take place during the colposcopy examination.
Treatment groups
1,060 Participants
are divided into 1 treatment groupGroup A: Experimental group - MMCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Develop and validate a Multimodal Mobile Colposcope (MMC)
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
Day 1 - at the colposcopy daySponsors and contacts
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Barretos Cancer Hospital
Lead sponsor
William Marsh Rice University
Collaborator
M.D. Anderson Cancer Center
Collaborator
Irmandade Santa Casa de Misericórdia de Porto Alegre
Collaborator
Source ClinicalTrials.gov