iMproving thE DIagnostics And Treatment Of ceRvical Precancer

NCT05870787 | Completed

• 1 other identifier: 2022-0367531-3031
• Study Type: observational
• Target: 929
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (2)

• Purpose 1: Diagnosis of collected targeted cervical biopsies

  The number of women diagnosed with Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) diagnosed in cervical biopsies

  When the histological report is available - typically within 12 weeks after the biopsy was taken

• Purpose 2: Diagnosis of collected random cervical biopsies

  The number of women diagnosed with Cervical Intraepithelial Neoplasia grade 1 or less (\<CIN1) vs. (CIN2+) diagnosed in random cervical biopsies. The clinical perspectives will be the absolute risk of CIN2+ in random biopsies.

  When the histological report is available - typically within 12 weeks after the biopsy was taken

Study Arms (2)

Swede score colposcopy

Swede score colposcopy: includes application with acetic acid, supplemented with a systematic scoring system (the Swede score) including Lugols iodine, and collection of cervical biopsies.

Diagnostic Test: Swede score colposcopy

Conventional colposcopy

Conventional colposcopy: includes application with acetic acid and collection of cervical biopsies.

Interventions

Swede score colposcopy DIAGNOSTIC_TEST

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

Swede score colposcopy

Eligibility Criteria

• Age: 23 Years - 99 Years
• Gender Eligibility Details: This study is focused on cervical cancer and precancer. Since only women have a cervix, only women will be included in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with abnormal smear (HPV-genotype and cytology) referred to colposcopy, visibel transformation zone (type 1 or 2) and where cervical biopsies has been sent to pathology examination.

You may qualify if:

• Women referred to colposcopy due to abnormal smear (HPV-genotype and cytology) in Central Denmark Region or Southern Denmark Region.

You may not qualify if:

• Allergic to iodine.
• Tranformationzone not visible (type 3).
• Atrophy of cervical epithelium.
• Women referred to colposcopy with no cervical biopsies taken or invalid cervical biopsies.
• Women with previous hysterectomy or without a cervix due to cervical cancer will be excluded.
• Pregnant women.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (7)

Guldberg Kvindeklinik

Fredericia, Fredericia, 7000, Denmark

Location

Gødstrup Regional Hospital

Herning, Herning, 7400, Denmark

Location

Horsens Gynækologisk Klinik

Horsens, Horsens, 8700, Denmark

Location

Horsens Regional Hospital

Horsens, Horsens, 8700, Denmark

Location

Odense Univeristy Hospital

Odense, Odense, 5000, Denmark

Location

Randers Regional Hospital

Randers, Randers, 8900, Denmark

Location

Viborg Regional Hospital

Viborg, Viborg, 8800, Denmark

Location

Related Publications (1)

• Knudsen AS, Randrup TH, Kesmodel US, Booth B, Gustafson L, Trope A, Strander B, Nieminen P, Hammer A. Assessment of a colposcopic scoring system (Swedescore) to reduce the number of cervical biopsies: a protocol for a clinical multicentre non-randomised intervention study in Denmark. BMJ Open. 2024 Dec 15;14(12):e085382. doi: 10.1136/bmjopen-2024-085382.

  PMID: 39675832 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Diseases; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Study Officials

• Anne Hammer, MD, as.prof

  University of Aarhus

  STUDY CHAIR

• Ulrik Schiøler Kesmodel, MD, prof

  Aalborg University Hospital

  STUDY CHAIR

• Berit Bargum Booth, MD, Ph.d.

  Randers Regional Hospital

  STUDY CHAIR

• Line Winther Gustafson, MD, Ph.d.

  Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 23, 2023
• Study Start: March 1, 2023
• Primary Completion: December 6, 2024
• Study Completion: December 13, 2024
• Last Updated: February 10, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (7)