Low-cost Imaging Technology for Global Prevention of Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multimodal Mobile Colposcope (MMC).
- Who it may be relevant to
- Registry conditions: Cervical Intraepithelial Neoplasia. Basic parameters: from 25 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer
Overview
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.
Interventions
- Device Multimodal Mobile Colposcope (MMC)
Women 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.
Primary outcome measures
- Develop and validate a Multimodal Mobile Colposcope (MMC) [Time frame: Day 1 - at the colposcopy day]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Brazil · 2 centers
- Irmandade Santa Casa de Misericórdia de Porto Alegre — Porto Alegre
- Barretos Cancer Hospital — Barretos
Publications
- Hunt B, Fregnani JHTG, Brenes D, Schwarz RA, Salcedo MP, Possati-Resende JC, Antoniazzi M, de Oliveira Fonseca B, Santana IVV, de Macedo Matsushita G, Castle PE, Schmeler KM, Richards-Kortum R. Cervical lesion assessment using real-time microendoscopy image analysis in Brazil: The CLARA study. Int J Cancer. 2021 Jul 15;149(2):431-441. doi: 10.1002/ijc.33543. Epub 2021 Apr 3. PMID 33811763
Identifiers
NCT: NCT05078528 · 38969820.9.1001.5437