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iMproving thE DIagnostics And Treatment Of ceRvical Precancer

NCT05870787 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 929

Last updated 2026-02-10

No results posted yet for this study

Summary

Cervical cancer screening is important as it enables identification of women at increased risk of the disease, but high-quality diagnostics of screen-positive women and effective treatment of those with precancer are critical in preventing progression to cancer. With the current transition from cytology-based to primary human papillomavirus (HPV)-screening and a growing proportion of HPV-vaccinated women, diagnostics of screen-positive women will become more challenging in the decades to come. Thus, there is a need to explore how to improve diagnostics while ensuring a low number of unnecessary procedures such as colposcopy and the collection of multiple cervical biopsies.

The overall purposes are:

Purpose 1: To investigate the diagnostic accuracy of cervical precancer when using a colposcopic scoring system in the diagnostic work-up of screen-positive women.

Purpose 2: To investigate the performance of a colposcopic scoring system to identify women without cervical precancer in whom collection of biopsies can be safely omitted.

Conditions

  • Cervical Dysplasia
  • Cervical Disease
  • Cervical Lesion
  • Cervical Cancer
  • Cervical Neoplasm

Interventions

DIAGNOSTIC_TEST

Swede score colposcopy

New colposcopy method: with application of acetic acid, supplemented with a systematic scoringsystem (Swede score) including Lugols iodine, and collection of cervical biopsies.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Berit Bargum Booth, MD, Ph.d. · Randers Regional Hospital

  • Anne Hammer, MD, as.prof · University of Aarhus

  • Ulrik Schiøler Kesmodel, MD, prof · Aalborg University Hospital

  • Line Winther Gustafson, MD, Ph.d. · Aarhus University Hospital

Eligibility

Min Age
23 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-12-06
Completion
2024-12-13

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05870787 on ClinicalTrials.gov