- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335372
Cervical Cancer Screening Study in Brazil
A Pilot Study of a Low-Cost Optical Imaging Tool for Cervical Cancer Screening in Brazil
Objectives:
Primary Objective: To perform a pilot clinical study to test multi-modal optical imaging for detection of cervical neoplasia in Brazil.
Secondary Objective: Analyze clinical data to establish the imaging modes which demonstrate the highest degree of correlation with disease state.
Study Overview
Status
Conditions
Detailed Description
Wide-field and high-resolution images of precancerous cervical lesions and normal uterine cervix will be obtained by imaging 357 patients, recruited from women presenting for colposcopic evaluation from the Prevention Department at Barretos Cancer Hospital, a MDACC Sister Institution, in Barretos, Brazil. Barretos Cancer Hospital will serve as the lead site for the study
Initial wide-field white light images will be acquired in unpolarized and cross-polarized modes before application of 3-6% acetic acid. Routine colposcopy involves visual inspection of the cervix for aceto-whitening and will be followed by a second pair of white-light images in each polarization mode. The clinician will identify all sites required for biopsy according to clinical impression, marking each location on the recorded unpolarized white light image. Topical application of 0.01% proflavine solution will then be applied for 1 minute, after which wide-field imaging in fluorescence mode will be performed. The clinician will then select up to 2 additional sites for biopsy based on the appearance of this wide-field fluorescence image, recording the location of each. The high-resolution microendoscope will then be used to acquire images at all sites selected for biopsy, followed by collection of biopsy specimens.
The entire imaging procedure should add less than 10 minutes to the standard colposcopy procedure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Barretos, Brazil, 14784-400
- Barretos Cancer Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergoing colposcopy
- 18 years of age or older
- Negative pregnancy test
- Subjects must be willing and able to provide informed consent
Exclusion Criteria:
- Patients under 18 years of age
- Positive pregnancy test
- Subjects unwilling and unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Multi-Modal Optical Imaging of Cervix
Initial wide-field white light images acquired of cervix in unpolarized and cross-polarized modes before application of 3-6% acetic acid.
The clinician will identify all sites required for biopsy according to clinical impression, marking each location on the recorded unpolarized white light image.
Topical application of 0.01% proflavine solution will then be applied for 1 minute, after which wide-field imaging in fluorescence mode will be performed.
The clinician will then select up to 2 additional sites for biopsy based on the appearance of this wide-field fluorescence image, recording the location of each.
The high-resolution microendoscope will then be used to acquire images at all sites selected for biopsy, followed by collection of biopsy specimens.
|
Initial wide-field white light images acquired of cervix in unpolarized and cross-polarized modes during cervical colposcopy.
3-6% acetic acid applied to cervix after wide-field while light imaging during colposcopy.
Topical application of 0.01% proflavine solution applied for 1 minute to cervix after sites for biopsy have been identified during colposcopy.
Wide-field imaging in fluorescence mode performed during cervical colposcopy after topical proflavine solution applied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Receiver Operating Characteristic (ROC) Curve for Classifying Cervical Tissue into One of 2 Diagnostic Categories
Time Frame: 1 day
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Data used to develop an algorithm to maximize the area under the receiver operating characteristic (ROC) curve for classifying tissue into one of 2 diagnostic categories (high grade squamous intraepithelial lesions; normal or low grade squamous intraepithelial lesions).
Descriptive statistics used to summarize the demographic and clinical characteristics of patients by diagnostic category.
Descriptive statistics and boxplots used to summarize nuclear size and N/C by diagnostic category.
Logistic regression methods used with the training set to model the logit of the probability of being classified as a high grade squamous intraepithelial lesion and to identify the parameters and threshold values which maximize the area under the ROC curve.
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1 day
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Uterine Cervical Neoplasms
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Antineoplastic Agents
- Immunologic Factors
- Protective Agents
- Anti-Bacterial Agents
- Adjuvants, Immunologic
- Anticarcinogenic Agents
- Proflavine
- Acetic Acid
- Retinol acetate
Other Study ID Numbers
- 2011-0396
- NCI-2015-00339 (REGISTRY: NCI CTRP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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