Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

Cervical Dysplasia Clinical Trial

Official title:

Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03502798
• Other study ID #: Pro00070555_1
• Secondary ID: R01CA167421
• Status: Completed
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: February 14, 2020

Study information

• Verified date: February 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 14, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Intervention

Device:
• scanning a/LCI
Imaging of the cervical epithelium using the scanning a/LCI device.

Locations

Country	Name	City	State
United States	Jacobi Medical Center	Bronx	New York
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Jacobi Medical Center, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline
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.	baseline
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	baseline