Colposcopy and Dynamic Spectral Imaging (DSI)

January 30, 2020 updated by: University of Aarhus

Does Dynamic Spectral Imaging (DSI) Colposcopy Improve the Diagnostics of Cervical Dysplasia Compared to Standard Colposcopy

This study evaluates the Dynamic Spectral Imaging (DSI) Colposcope (DySIS) in it's ability to diagnose cervical dysplasia. Half of participants with be examined by the DySIS colposcope, there the other half will be examined by standard colposcopy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Colposcopy has been shown to be a subjective exam, and is dependant on the colposcopists. Sensitivity for colposcopy has been shown to be as low as 50%.

To improve this, different adjunctive technologies have been introduced to add a more objective approach to the colposcopy exam. One of these devices is the DySIS colposcope, which measures the aceto-white reaction that may occur on the cervix uteri after the application of acetic-acid. The device provides the examiner with a colour-coded map indicating areas of interest. Studies have shown promising results indicating that using this device together with the colposcopists own interpretation of the cervix uteri can potentially lead to an increase in the performance of the colposcopy exam.

In Denmark all women referred for colposcopy have 4 biopsies taken, according to the Danish national guidelines.

In our study these 4 biopsies are as following:

  1. The area the colposcopists views as the worst before the DSI-map is seen. Colposcopy-Directed Biopsy (CDB)
  2. The area indicated as the worst by the DSI-map (DSI-directed biopsy)
  3. additional biopsy
  4. additional biopsy All biopsies are placed in separate containers and analysed separately by specialized pathologists.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Withdrawn
        • Aalborg University Hospital
      • Aarhus, Denmark, 8000
        • Completed
        • Private Gynaecology Clinic
      • Horsens, Denmark, 8700
        • Recruiting
        • Horsens Regional Hospital
        • Contact:
          • Christina B Kristensen, MD
    • Danmark
      • Randers, Danmark, Denmark, 8930
        • Recruiting
        • Randers Regional Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All women above the age of 18 who are referred for colposcopy due to an abnormal cervical smear (ASCUS, LSIL, ASC-H, HSIL, ACG or CIS) or as follow up to previously diagnosed CIN. The women cannot be included if they have had cervical biopsies taken within the last 6 months, have previously had a cone biopsy taken, are currently pregnant or have been pregnant within the last 3 months.

Description

Inclusion Criteria:

  • Referred for colposcopy due to a cervical smear test of Atypical Squamous Cells of Undetermined Significance (ASCUS), low-grade intraepithelial lesion (LSIL), atypical squamous cells, cannot exclude a high-grade lesion (ASC-H), high-grade intraepithelial lesion (HSIL), Atypical glandular cells (ACG) or carcinoma in situ (CIS)
  • Referred for colposcopy due to follow-up of previously diagnosed CIN (If there has been a minimum of 6 months since previous cervical biopsies)

Exclusion Criteria:

  • Cervical biopsies taken within the last 6 months
  • Previous cone procedure
  • Currently pregnant
  • Pregnant within the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women examined by colposcopy
Women referred to colposcopy at our facilities who met inclusion criteria
Diagnostic test: Dynamic Spectral Imaging (DYSIS)
Women who have a colposcopy exam performed at Randers Regional Hospital were examined by Dynamic Spectral Imaging colposcopy (DYSIS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of women found with a histological diagnosis of Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) in colposcopy-directed biopsy (CDB)
Time Frame: when the histological report is available - typically 4 weeks after the biopsy was taken.

The proportion of women who are found with a histological CIN2+ diagnosis in the cervical punch biopsy from the area chosen by the colposcopist before the DSI-map became visible (will be referred to as the Colposcopy directed biopsy (CDB)).

The diagnosis of the biopsy will be recorded when the histological report is available.

Further treatment needs for the patient will be based on the national clinical guidelines on cervical dysplasia.
when the histological report is available - typically 4 weeks after the biopsy was taken.
Proportion of women found with a histological diagnosis of CIN2 or worse in DSI-directed biopsies
Time Frame: when the histological report is available - typically 4 weeks after the biopsy was taken.

The proportion of women who are found with a histological CIN2+ diagnosis in cervical punch biopsy taken from the worst area indicated by the DSI-map (referred to as the DSI-directed biopsy) The diagnosis of the biopsy will be recorded when the histological report is available.

Further treatment needs for the patient will be based on the national clinical guidelines on cervical dysplasia.
when the histological report is available - typically 4 weeks after the biopsy was taken.
Proportion of women found with a histological diagnosis of CIN2 or worse in 2 additional random biopsies
Time Frame: when the histological report is available - typically 4 weeks after the biopsy was taken.

The amount of women who are found with a histological CIN2+ diagnosis in cervical punch biopsies taken from 2 additional areas besides the CDB and the DSI-directed areas.

The diagnosis of the biopsy will be recorded when the histological report is available.

Further treatment needs for the patient will be based on the national clinical guidelines on cervical dysplasia.
when the histological report is available - typically 4 weeks after the biopsy was taken.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance of cervical punch biopsies and cone biopsy
Time Frame: When both histological reports were available these were compared.
Comparing the histological diagnosis of the cervical punch biopsies to the cone biopsy, in women who are referred for conization based on the histological outcome of the colposcopy procedure.
When both histological reports were available these were compared.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Berit B Booth, MD, University of Aarhus
  • Study Chair: Pinar Bor, MD, PhD, Randers Regional Hospital
  • Study Chair: Lone K Petersen, MD, Med.Sc.D., Odense University Hospital
  • Study Chair: Jan Blaakaer, MD, Med.Sc.D., Odense University Hospital
  • Study Chair: Katja Dahl, MD, PhD, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2017

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

October 31, 2020

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (ACTUAL)

January 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 30, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSIcolposcopy_DK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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