Cervical lesion assessment using real-time microendoscopy image analysis in Brazil: The CLARA study.
Brady Hunt, José Humberto Tavares Guerreiro Fregnani, David Brenes...
https://pubmed.ncbi.nlm.nih.gov/33811763/Actively Recruiting
Led by Barretos Cancer Hospital · Updated on 2025-02-06
1060
Participants Needed
2
Research Sites
17 weeks
Total Duration
Cervical cancer is a leading cause of cancer death among women in many low- and middle-income countries. Prevention efforts in these areas face challenges such as shortages of skilled personnel, lack of pathology services, and limited infrastructure. This research aims to develop and validate a low-cost Multimodal Mobile Colposcope MMC that combines mobile colposcopy and fiber-optic confocal microscopic imaging to improve cervical cancer screening and diagnosis globally. Participants in this study will undergo imaging during their colposcopy examination using the MMC device. This includes capturing images or videos of the cervix with both the mobile colposcope and the confocal imaging probe. Cervical biopsies will also be performed following standard clinical protocols as part of the evaluation process. Women referred for colposcopy due to abnormal cervical screening or follow-up for cervical dysplasia will take part in this study. Researchers will collect imaging data and perform biopsies to develop and validate the MMC device on the day of colposcopy. The primary measure is the performance of the MMC device during this examination. Participants will be monitored during their visit, and their informed consent will be obtained before participation.
CONDITIONS
Low-cost Imaging Technology for Global Prevention of Cervical Cancer
J
Júlio César P Resende, MD, PhD
M
Mila P Salcedo, MD, PhD
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Barretos Cancer Hospital
Lead Sponsor
William Marsh Rice University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo imaging of the cervix using the Multimodal Mobile Colposcope (MMC) during the colposcopy examination. Cervical biopsies are performed as per standard protocols.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Brady Hunt, José Humberto Tavares Guerreiro Fregnani, David Brenes...
https://pubmed.ncbi.nlm.nih.gov/33811763/Barretos Cancer Hospital
Lead Sponsor
William Marsh Rice University
Collaborating Sponsor