Back to resultsLow-cost Imaging Technology for Global Prevention of Cervical Cancer
Primary Purpose
Cervical Intraepithelial Neoplasia
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Multimodal Mobile Colposcope (MMC)
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Intraepithelial Neoplasia focused on measuring image analysis, cancer prevention, cervical intraepithelial neoplasia
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;
Sites / Locations
- Irmandade Santa Casa de Misericórdia de Porto AlegreRecruiting
- Barretos Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental group - MMC
Arm Description
Imaging of study participants will be performed during the colposcopy examination. The mobile colposcope and the confocal imaging probe, together referred to as the Multimodal Mobile Colposcope (MMC), will be used to image and/or record videos the cervix. Cervical biopsies will be performed using biopsy forceps per standard protocols.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05078528
First Posted
October 4, 2021
Last Updated
February 7, 2023
Sponsor
Barretos Cancer Hospital
Collaborators
William Marsh Rice University, M.D. Anderson Cancer Center, Irmandade Santa Casa de Misericórdia de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT05078528
Brief Title
Low-cost Imaging Technology for Global Prevention of Cervical Cancer
Official Title
Low-cost Mobile Colposcopy and Confocal Imaging for Global Prevention of Cervical Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
April 3, 2025 (Anticipated)
Study Completion Date
December 3, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barretos Cancer Hospital
Collaborators
William Marsh Rice University, M.D. Anderson Cancer Center, Irmandade Santa Casa de Misericórdia de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia
Keywords
image analysis, cancer prevention, cervical intraepithelial neoplasia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1060 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group - MMC
Arm Type
Experimental
Arm Description
Imaging of study participants will be performed during the colposcopy examination. The mobile colposcope and the confocal imaging probe, together referred to as the Multimodal Mobile Colposcope (MMC), will be used to image and/or record videos the cervix. Cervical biopsies will be performed using biopsy forceps per standard protocols.
Intervention Type
Device
Intervention Name(s)
Multimodal Mobile Colposcope (MMC)
Intervention Description
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 Measure Information:
Title
Develop and validate a Multimodal Mobile Colposcope (MMC)
Description
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 day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Júlio César P Resende, MD, PhD
Phone
+55 (17) 3321-6600
Ext
7086
Email
julio.possati@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Mila P Salcedo, MD, PhD
Phone
+1-832-316-3774
Email
mpsalcedo@mdanderson.org
Facility Information:
Facility Name
Irmandade Santa Casa de Misericórdia de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mila P Salcedo, MD, PhD
Facility Name
Barretos Cancer Hospital
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Júlio César P Resende, MD,PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33811763
Citation
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.
Results Reference
result
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Low-cost Imaging Technology for Global Prevention of Cervical Cancer
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