Cervical DysplasiaNCT03502798

Coherence Imaging of the Cervical Epithelium With Scanning a/LCI

A study testing scanning a/LCI in people with Cervical Dysplasia, run by Duke University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 21 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Cervical Dysplasia
What is being tested?: scanning a/LCI
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 2 sitesUnited States
Study dates: 8 Nov 2018to 14 Feb 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

able to provide informed consent
willing to abstain from sexual intercourse for at least 24 hours before study visit

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Duke University Medical Center
Durham, North Carolina, 27710
Jacobi Medical Center
The Bronx, New York, 10461

Other trials in United States

About this study

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).

Conditions: Cervical Dysplasia
Being tested: scanning a/LCI
Medical subject headings: Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

scanning a/LCIDevice
Imaging of the cervical epithelium using the scanning a/LCI device.

Study groups in NCT03502798
Study group	Role	What they receive
scanning a/LCI	Experimental	Not described Receives: Device: scanning a/LCI

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: baseline

Secondary outcomes (1)

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
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 201814 Feb 2020

First posted19 Apr 2018
Study start8 Nov 2018
Primary completion14 Feb 2020
Study completion14 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cervical DysplasiaStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03502798
Sponsor's protocol ID: Pro00070555_1
Other IDs: R01CA167421
Status last verified: Feb 2021
First submitted: 11 Apr 2018
Last updated: 18 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cervical Dysplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Coherence Imaging of the Cervical Epithelium With Scanning a/LCI
ClinicalTrials.gov ID: NCT03502798
Acronym / sponsor ID: Pro00070555_1
Conditions: Cervical Dysplasia
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), Jacobi Medical Center
Study start: 8 Nov 2018 (actual)
Primary completion: 14 Feb 2020 (actual)
Study completion: 14 Feb 2020 (actual)
First posted: 19 Apr 2018 (actual)
Results: Posted 18 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
scanning a/LCI	Experimental	Device: scanning a/LCI

Who may qualify

Ages: 21 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

able to provide informed consent
willing to abstain from sexual intercourse for at least 24 hours before study visit

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
scanning a/LCIImaging of the cervical epithelium using the scanning a/LCI device.	Device	scanning a/LCI

Primary outcome

Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies
Time frame: 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
Time frame: 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.

1 secondary outcome

Identification of T-zone by Scanning a/LCI Probe
Time frame: baseline

Results and safety

Results posted to the registry on 18 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Scanning a/LCI (Pilot)	5	5
Scanning a/LCI (Jacobi)	40	33

Primary outcome: Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies

Time frame: baseline. Number (95% Confidence Interval). Unit: percentage of correct identifications

Measure	Scanning a/LCI (Pilot) n = 0	Scanning a/LCI (Jacobi) n = 20
histology-based classification	–	90.3 (74.2 to 98.0)
response-based classification	–	100.0 (73.5 to 100.0)

Population analysed: 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.

Primary outcome: Specificity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Negative Optical Biopsies

Time frame: baseline. Number (95% Confidence Interval). Unit: percentage of correct identifications

Measure	Scanning a/LCI (Pilot) n = 0	Scanning a/LCI (Jacobi) n = 20
histology-based classification	–	81.6 (68.0 to 91.2)
response-based classification	–	70.6 (58.3 to 81.0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day of study only. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Scanning a/LCI (Pilot)	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Scanning a/LCI (Jacobi)	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Limitations and caveats (from the sponsor): The fragility of the instrument resulted in repeated breakage. Traveling from Durham to NYC to retrieve the broken instrument, repair it, and send it back several times set the timeline back substantially, resulting in insufficient time to perform the secondary outcome measure. Instrument fragility, complexity of instrument set up and initiation, and poor signal quality are responsible for the low yield of evaluable a/LCI scans.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adam Wax, Ph.D. principal investigator

professor

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing scanning a/LCI in people with Cervical Dysplasia, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03502798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.