Clinical trial · Observational
iMproving thE DIagnostics And Treatment Of ceRvical Precancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Disease | — | UNRESOLVED | — |
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Cervical Lesion | — | UNRESOLVED | — |
| Cervical Neoplasm | Cervical Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Swede score colposcopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Swede score colposcopy
- description
- 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.
- interventionNames
- Diagnostic Test: Swede score colposcopy
- label
- Conventional colposcopy
- description
- Conventional colposcopy: includes application with acetic acid and collection of cervical biopsies.
Primary outcomes (2)
- measure
- Purpose 1: Diagnosis of collected targeted cervical biopsies
- timeFrame
- When the histological report is available - typically within 12 weeks after the biopsy was taken
- description
- The number of women diagnosed with Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) diagnosed in cervical biopsies
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 23 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Women referred to colposcopy due to abnormal smear (HPV-genotype and cytology) in Central Denmark Region or Southern Denmark Region. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDKnudsen 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