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/33811763Actively Recruiting
Phase Not Applicable
Age: 25Years +
FEMALE
ID05078528
Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer
Led by Barretos Cancer Hospital · Updated on 2025-02-06
1060
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
Sponsors
B
Barretos Cancer Hospital
Lead Sponsor
W
William Marsh Rice University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
Low-cost Imaging Technology for Global Prevention of Cervical Cancer
Who Can Participate
Age: 25Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Women older than 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
You will not qualify if you...
- 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
- Incapacitated women or in vulnerable situations or who are not willing to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
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)
Trial Site Locations
Total: 2 locations
1
Irmandade Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Actively Recruiting
2
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
Loading map...
Research Team
J
Júlio César P Resende, MD, PhD
M
Mila P Salcedo, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here