An interventional study of scanning a/LCI in Cervical Dysplasia, sponsored by Duke University. Completed at 2 sites in United States. Open to female participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Duke University · Not applicable, Interventional, and Diagnostic
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:
356 studies on the registry are indexed under Uterine Cervical Dysplasia; 68 are open to participants now.
This study's enrollment of 45 is below the median of 166 across 249 interventional studies indexed under Uterine Cervical Dysplasia.
Browse Uterine Cervical Dysplasia studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: scanning a/LCI
Imaging of the cervical epithelium using the scanning a/LCI device.
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
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
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
| Milestone | Scanning a/LCI (Pilot) | Scanning a/LCI (Jacobi) |
|---|---|---|
| Started | 5 | 40 |
| Completed | 5 | 33 |
| Not completed | 0 | 7 |
| Withdrew: Equipment failure | 0 | 7 |
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.
| percentage of correct identifications | Scanning a/LCI (Pilot) | Scanning a/LCI (Jacobi) |
|---|---|---|
| histology-based classification | — | 90.3 (74.2 to 98.0) |
| response-based classification | — | 100.0 (73.5 to 100.0) |
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.
| percentage of correct identifications | Scanning a/LCI (Pilot) | Scanning a/LCI (Jacobi) |
|---|---|---|
| histology-based classification | — | 81.6 (68.0 to 91.2) |
| response-based classification | — | 70.6 (58.3 to 81.0) |
Ability of scanning a/LCI probe to correctly identify transformation zone (T-zone) compared to colpophotography
No measurements were reported for this outcome.
Collected over Day of study only. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Scanning a/LCI (Pilot) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Scanning a/LCI (Jacobi) | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(years) | Scanning a/LCI (Pilot) | Scanning a/LCI (Jacobi) | Total |
|---|---|---|---|
| Mean | 26 (21 to 34) | 35 (23 to 49) | 34 (21 to 49) |
| Sex: Female, Male(Participants) | Scanning a/LCI (Pilot) | Scanning a/LCI (Jacobi) | Total |
|---|---|---|---|
| Female | 5 | 40 | 45 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Scanning a/LCI (Pilot) | Scanning a/LCI (Jacobi) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 23 | 23 |
| Not Hispanic or Latino | 5 | 14 | 19 |
| Unknown or Not Reported | 0 | 3 | 3 |
| Race (NIH/OMB)(Participants) | Scanning a/LCI (Pilot) | Scanning a/LCI (Jacobi) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 11 | 13 |
| White | 2 | 17 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 11 | 11 |
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