Cervical Dysplasia
Conditions
Brief summary
The purpose of this study is to develop a low coherence interferometry (LCI) endoscopic probe that can examine the cervix for evidence of cervical dysplasia. The device will make optical measurements of the cervix to determine: 1. the difference between two different types of cervical cells: ectocervical cells and endocervical cells. Cervical dysplasia is most likely to occur at the junction between these two types of cells. 2. features of individual cervical cells that indicate whether the cell is normal or abnormal (cervical dysplasia).
Interventions
DEVICEscanning a/LCI
Imaging of the cervical epithelium using the scanning a/LCI device.
Sponsors
National Cancer Institute (NCI)
Jacobi Medical Center
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
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 * 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 |
|---|---|---|
| Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies | baseline | Sensitivity of the scanning a/LCI probe's ability to detect cervical dysplasia determined by calculating the percentage of correctly identified positive optical biopsies measured by the scanning a/LCI probe when compared to the gold standard, histopathology. There are two dichotomies of classification used in this study: one that focuses on the morphological differences between cells (histology-based classification), and one that focuses on the urgency of corresponding treatment (response-based classification). In the histology-based classification, a result of benign alone is a negative result and a result of LSIL (low-grade squamous intraepithelial lesion) or HSIL (high-grade squamous epithelial lesion) is a positive result. In the response-based classification, both benign and LSIL are treated as negative results and HSIL is treated as a positive result. |
| Specificity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Negative Optical Biopsies | baseline | Specificity of the scanning a/LCI probe's ability to detect cervical dysplasia determined by calculating the percentage of correctly identified negative optical biopsies measured by the scanning a/LCI probe when compared to the gold standard, histopathology. There are two dichotomies of classification used in this study: one that focuses on the morphological differences between cells (histology-based classification), and one that focuses on the urgency of corresponding treatment (response-based classification). In the histology-based classification, a result of benign alone is a negative result and a result of LSIL (low-grade squamous intraepithelial lesion) or HSIL (high-grade squamous intraepithelial lesion) is a positive result. In the response-based classification, both benign and LSIL are treated as negative results and HSIL is treated as a positive result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of T-zone by Scanning a/LCI Probe | baseline | Ability of scanning a/LCI probe to correctly identify transformation zone (T-zone) compared to colpophotography |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Scanning a/LCI (Pilot) Pilot study conducted at Duke University (Durham, NC). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test.
The scanning a/LCI probe was inserted into the vagina and placed against the cervix using direct visualization provided by a white light camera incorporated into the probe. Optical interferometric data were acquired to characterize the instrument's ability to detect cervical dysplasia via depth-resolved nuclear morphology measurements. | 5 |
| Scanning a/LCI (Jacobi) Primary arm of present study, conducted at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included: current gynecological infection or discharge, prior cervical surgery, or positive urine pregnancy test. In addition, participants abstained from sexual intercourse for at least 24 hours prior to the study visit.
A speculum was inserted prior to the a/LCI probe for ease of tissue biopsy collection after a/LCI scanning. The scanning a/LCI probe was inserted through speculum and placed against the cervix using white light visual guidance from the probe's integrated camera. The a/LCI imaging sequence was initiated, with 36 scan points spaced across an area of 50 mm2. 80 a/LCI optical biopsy scans were at 4 selected biopsy sites (20 per quadrant). The a/LCI probe was removed and a Wallach colposcope was used to take a digital image of the cervix for co-registration with the a/LCI image. Some women underwent a previously scheduled loop electrosurgical excision procedure (LEEP) immediately following data collection; tissue biopsies were taken either with the assistance of the colposcope or during the LEEP and all specimens were analyzed by pathologists to provide a histological diagnosis for comparison with the a/LCI measurements. Tissue biopsies for each quadrant were assigned a classification (negative, CIN-1, CIN-2, or CIN-3) as well as notes for any additional findings (koilocytic atypia, abnormal acetowhite epithelium, etc.). | 40 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | equipment failure | 0 | 7 |
Baseline characteristics
| Characteristic | Total | Scanning a/LCI (Jacobi) | Scanning a/LCI (Pilot) |
|---|---|---|---|
| Age, Continuous | 34 years | 35 years | 26 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 23 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 14 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 11 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 | 11 Participants | 11 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 17 Participants | 2 Participants |
| Sex: Female, Male Female | 45 Participants | 40 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 / 40 |
| other Total, other adverse events | 0 / 5 | 0 / 40 |
| serious Total, serious adverse events | 0 / 5 | 0 / 40 |
Outcome results
Primary
Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies
Sensitivity of the scanning a/LCI probe's ability to detect cervical dysplasia determined by calculating the percentage of correctly identified positive optical biopsies measured by the scanning a/LCI probe when compared to the gold standard, histopathology. There are two dichotomies of classification used in this study: one that focuses on the morphological differences between cells (histology-based classification), and one that focuses on the urgency of corresponding treatment (response-based classification). In the histology-based classification, a result of benign alone is a negative result and a result of LSIL (low-grade squamous intraepithelial lesion) or HSIL (high-grade squamous epithelial lesion) is a positive result. In the response-based classification, both benign and LSIL are treated as negative results and HSIL is treated as a positive result.
Time frame: baseline
Population: 40 women enrolled at the Jacobi site, but successful a/LCI scans were only acquired from 20 participants due to equipment failures (mechanical breaks in probe, electrical component failures, software errors). For each participant analyzed, optical biopsies (a/LCI scans) and corresponding physical tissue biopsies were collected at four sites (12, 3, 6, and 9 o'clock). No pilot study participants were analyzed as no physical tissue biopsies were done in the pilot phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scanning a/LCI (Jacobi) | Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies | histology-based classification | 90.3 percentage of correct identifications |
| Scanning a/LCI (Jacobi) | Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies | response-based classification | 100.0 percentage of correct identifications |
Primary
Specificity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Negative Optical Biopsies
Specificity of the scanning a/LCI probe's ability to detect cervical dysplasia determined by calculating the percentage of correctly identified negative optical biopsies measured by the scanning a/LCI probe when compared to the gold standard, histopathology. There are two dichotomies of classification used in this study: one that focuses on the morphological differences between cells (histology-based classification), and one that focuses on the urgency of corresponding treatment (response-based classification). In the histology-based classification, a result of benign alone is a negative result and a result of LSIL (low-grade squamous intraepithelial lesion) or HSIL (high-grade squamous intraepithelial lesion) is a positive result. In the response-based classification, both benign and LSIL are treated as negative results and HSIL is treated as a positive result.
Time frame: baseline
Population: 40 women enrolled at the Jacobi site, but successful a/LCI scans were only acquired from 20 participants due to equipment failures (mechanical breaks in probe, electrical component failures, software errors). For each participant analyzed, optical biopsies (a/LCI scans) and corresponding physical tissue biopsies were collected at four sites (12, 3, 6, and 9 o'clock). No pilot study participants were analyzed as no physical tissue biopsies were done in the pilot phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scanning a/LCI (Jacobi) | Specificity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Negative Optical Biopsies | histology-based classification | 81.6 percentage of correct identifications |
| Scanning a/LCI (Jacobi) | Specificity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Negative Optical Biopsies | response-based classification | 70.6 percentage of correct identifications |
Secondary
Identification of T-zone by Scanning a/LCI Probe
Ability of scanning a/LCI probe to correctly identify transformation zone (T-zone) compared to colpophotography
Time frame: baseline
Population: Data not collected due to frequent instrument repairs.