NCT04249856

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

January 31, 2020

Status Verified

December 1, 2019

Enrollment Period

3.3 years

First QC Date

January 23, 2020

Last Update Submit

January 30, 2020

Conditions

Cervical DysplasiaCervical DiseaseCervical LesionCervix CancerCervical CancerCervical Neoplasm

Keywords

ColposcopyDynamic Spectral Imaging, DySISColposcopy Directed Biopsy

Outcome Measures

Primary Outcomes (3)

  • Proportion of women found with a histological diagnosis of Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) in colposcopy-directed biopsy (CDB)

    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

    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

    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 Outcomes (1)

  • Concordance of cervical punch biopsies and cone biopsy

    When both histological reports were available these were compared.

Study Arms (1)

Women examined by colposcopy

Women referred to colposcopy at our facilities who met inclusion criteria

Diagnostic Test: Dynamic Spectral Imaging (DYSIS)

Interventions

Dynamic Spectral Imaging (DYSIS)DIAGNOSTIC_TEST

Women who have a colposcopy exam performed at Randers Regional Hospital were examined by Dynamic Spectral Imaging colposcopy (DYSIS)

Women examined by colposcopy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Randers Regional Hospital

Randers, Danmark, 8930, Denmark

RECRUITING

Aalborg University Hospital

Aalborg, 9000, Denmark

WITHDRAWN

Private Gynaecology Clinic

Aarhus, 8000, Denmark

COMPLETED

Horsens Regional Hospital

Horsens, 8700, Denmark

RECRUITING

Related Publications (2)

  • Jespersen MM, Booth BB, Petersen LK. Can biopsies be omitted after normal colposcopy in women referred with low-grade cervical cytology? A prospective cohort study. BMC Womens Health. 2021 Nov 19;21(1):394. doi: 10.1186/s12905-021-01537-5.

    PMID: 34798899DERIVED

  • Booth BB, Petersen LK, Blaakaer J, Johansen T, Mertz H, Dahl K, Bor P. Can the dynamic spectral imaging (DSI) color map improve colposcopy examination for precancerous cervical lesions? A prospective evaluation of the DSI color map in a multi-biopsy clinical setting. BMC Womens Health. 2021 Jan 12;21(1):21. doi: 10.1186/s12905-020-01169-1.

    PMID: 33435974DERIVED

Biospecimen

Cervical punch biopsies

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical DiseasesUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by Site

Study Officials

  • Berit B Booth, MD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Central Study Contacts

Berit B Booth, MD

CONTACT

+4528587858berit.booth@auh.rm.dk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 31, 2020

Study Start

February 1, 2017

Primary Completion

June 1, 2020

Study Completion

October 31, 2020

Last Updated

January 31, 2020

Record last verified: 2019-12

Locations

DK(4)