Cervical Epithelia
Conditions
Brief summary
The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI) endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will obtain optical measurements from the cervix. These measurements can be used to create a map of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most likely to occur.
Interventions
DEVICEmLCI Device
imaging of cervical epithelium using mLCI device
Sponsors
National Cancer Institute (NCI)
Jacobi Medical Center
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
Yes
Inclusion criteria
* able to provide informed consent * willing to abstain from sexual intercourse for at least 24 hours before study visit
Exclusion criteria
* pregnant * using an intrauterine device (IUD) * have a current gynecological infection or discharge * have had any cervical surgery * had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months * currently enrolled in any research studies involving the application of vaginal formulations * employed or supervised by the study investigators * have any other condition, that, in the opinion of the study clinician, would contraindicate participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Interferometric Data Acquired From Cervical Epithelium | day 1 | measured by: ability to receive interferometric data from at least one portion of the cervical epithelium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Automated Classification of Cervical Epithelium | day 1 | The number of patients for which an interferometric tissue classification was made using optical mLCI data |
| Number and Frequency of Adverse Events | day 1 | Number of adverse events experienced by patients during the mLCI study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| mLCI Imaging (Pilot) Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test. | 5 |
| mLCI Imaging (Jacobi) Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type. | 50 |
| Total | 55 |
Baseline characteristics
| Characteristic | mLCI Imaging (Jacobi) | Total | mLCI Imaging (Pilot) |
|---|---|---|---|
| Age, Continuous | 29.4 years | 29.4 years | 29.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 16 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 39 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 28 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 16 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 8 Participants | 3 Participants |
| Sex: Female, Male Female | 50 Participants | 55 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 50 |
| other Total, other adverse events | 0 / 5 | 0 / 50 |
| serious Total, serious adverse events | 0 / 5 | 0 / 50 |
Outcome results
Primary
Number of Patients With Interferometric Data Acquired From Cervical Epithelium
measured by: ability to receive interferometric data from at least one portion of the cervical epithelium
Time frame: day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mLCI Imaging (Pilot) | Number of Patients With Interferometric Data Acquired From Cervical Epithelium | 3 patients |
| mLCI Imaging (Jacobi) | Number of Patients With Interferometric Data Acquired From Cervical Epithelium | 41 patients |
Secondary
Number and Frequency of Adverse Events
Number of adverse events experienced by patients during the mLCI study.
Time frame: day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mLCI Imaging (Pilot) | Number and Frequency of Adverse Events | 0 events |
| mLCI Imaging (Jacobi) | Number and Frequency of Adverse Events | 0 events |
Secondary
Number of Patients With Automated Classification of Cervical Epithelium
The number of patients for which an interferometric tissue classification was made using optical mLCI data
Time frame: day 1
Population: Patients from whom epithelial interferometric data were successfully captured and for whom a corresponding colposcope image could be registered. No pilot study patients were included as no colposcopic examination was conducted in the pilot phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| mLCI Imaging (Jacobi) | Number of Patients With Automated Classification of Cervical Epithelium | 36 patients |