Clinical trial NCT02335372: Cervical Cancer Screening Study in Brazil
Official title: A Pilot Study of a Low-Cost Optical Imaging Tool for Cervical Cancer Screening in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical cancer
Cervical neoplasia
Cervical cancer screening
Colposcopy
Wide-field white light imaging
Wide-field fluorescence imaging
Acetic acid
Proflavine solution
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing colposcopy
2. 18 years of age or older
3. Negative pregnancy test
4. Subjects must be willing and able to provide informed consent

Exclusion Criteria:

1. Patients under 18 years of age
2. Positive pregnancy test
3. Subjects unwilling and unable to provide informed consent

Primary outcomes:
measure: Area Under the Receiver Operating Characteristic (ROC) Curve for Classifying Cervical Tissue into One of 2 Diagnostic Categories
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos Cancer Hospital
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kathleen Schmeler, MD
role: PRINCIPAL_INVESTIGATOR
References: