Cervical Pre-cancer
Conditions
Brief summary
The purpose of this study is to see if the transvaginal colposcope produces similar results to colposcopy for the screening of cervical cancer. In this study the investigators are using an investigational device called the transvaginal colposcope. The word investigational means that the device is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
Interventions
DEVICEtransvaginal digital colposcope (TVDC)
TVDC is a miniature colposcope used to obtain images of cervical tissue.
OTHERStandard of care screening
Standard of care screening varies from institution to institution but is either visual inspection with the naked eye, colposcopy, or visual inspection with a camera or microscope
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the treatment of cervical cancer. * Age 25 and greater * Patients of all ethnic backgrounds will be included. * Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
* Children and subjects under 25.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree | Up to approximately 10 minutes |
Countries
India, Peru, Tanzania, United States, Zambia
Participant flow
Recruitment details
Cervical images obtained across 6 countries to build a database of 1000+ images to develop AI software for cervical cancer screening.
Participants by arm
| Arm | Count |
|---|---|
| Transvaginal Digital Colposcope (TVCD) Each enrolled patient will undergo the standard of care for cervical cancer screening at her institution, and then the trans-vaginal colposcope will be used to collect digital images of the cervix.
transvaginal digital colposcope (TVDC): TVDC is a miniature colposcope used to obtain images of cervical tissue. | 514 |
| Total | 514 |
Baseline characteristics
| Characteristic | Transvaginal Digital Colposcope (TVCD) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 514 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 200 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 314 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 125 Participants |
| Race (NIH/OMB) Black or African American | 189 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 200 Participants |
| Region of Enrollment India | 125 participants |
| Region of Enrollment Peru | 200 participants |
| Region of Enrollment Tanzania | 100 participants |
| Region of Enrollment Zambia | 89 participants |
| Sex: Female, Male Female | 514 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 514 |
| other Total, other adverse events | 0 / 514 |
| serious Total, serious adverse events | 0 / 514 |
Outcome results
Primary
Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree
Time frame: Up to approximately 10 minutes
Population: We have SOC Images from these 514 participants AND the images obtained with our research device. Therefore we have 2 photos for each step in the colposcopy procedure process
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transvaginal Digital Colposcope (TVCD) | Number of Participants for Which the Standard of Care Diagnosis and the Diagnosis of the TVDC Image Agree | 514 Participants |