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Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

Primary Purpose

Cervical Dysplasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
scanning a/LCI
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Dysplasia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Jacobi Medical Center
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

scanning a/LCI

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
April 11, 2018
Last Updated
February 1, 2021
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI), Jacobi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03502798
Brief Title
Coherence Imaging of the Cervical Epithelium With Scanning a/LCI
Official Title
Coherence Imaging of the Cervical Epithelium With Scanning a/LCI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI), Jacobi Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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: 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. features of individual cervical cells that indicate whether the cell is normal or abnormal (cervical dysplasia).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dysplasia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
scanning a/LCI
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
scanning a/LCI
Intervention Description
Imaging of the cervical epithelium using the scanning a/LCI device.
Primary Outcome Measure Information:
Title
Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies
Description
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
Title
Specificity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Negative Optical Biopsies
Description
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
Secondary Outcome Measure Information:
Title
Identification of T-zone by Scanning a/LCI Probe
Description
Ability of scanning a/LCI probe to correctly identify transformation zone (T-zone) compared to colpophotography
Time Frame
baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Wax, Ph.D.
Organizational Affiliation
professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

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