Clinical trial · Interventional
See and Treat in an Outpatient Setting in Women Above 45 Years With Cervical Dysplasia
NCT04298957CI-TRIAL-00058563completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The study will investigate if implementation of "see and treat" in the outpatient clinic can optimize the diagnosis, clinical follow-up and treatment of older women with positive cervical screening test.
Conditions
Conditions (3)
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 Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Cervical Lesion | — | UNRESOLVED | — |
| Cervix Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cone biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- See and treat
- description
- Cone biopsi is offered to women age ≥ 45 years referred to Department of Obstetrics and Gynecology due to a positive cervical screening test and partly or invisible transformation zone.
- interventionNames
- Procedure: Cone biopsy
Primary outcomes (4)
- measure
- Cervical intraepithelial neoplasia ≥ grade 2 (CIN2+) lesion after referral with a positive cervical screening test
- timeFrame
- The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.
- description
- The prevalence of CIN2+ lesions in women ≥45 years included in the study
- measure
- Concordance between cytology and histology
- timeFrame
- The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Women ≥ 45 years with a positive screening test (abnormal cytology and/or persistence HPV positive) who are referred to the Department of Obstetrics and Gynecology. * Type 2 or 3 transformation zone (a partly or invisible transformation zone). Exclusion Criteria: * Type 1 transformation zone (fully visible) * Current or previous diagnosis of cervical cancer. * Pregnancy or pregnancy wish. * Previously cone biopsy
References
Publications (2)
- DERIVEDBinderup KO, Boers J, Gustafson LW, Andersen B, Petersen LK, Bor P, Gribnau J, Quint WGV, Van Den Munckhof H, Tranberg M, Hammer A. DNA-Methylation for Risk-Stratification of Women Without a Fully Visible Transformation Zone at Colposcopy: A Cross-Sectional Study. BJOG. 2025 Jul 14. doi: 10.1111/1471-0528.18288. Online ahead of print. PMID 40654017
- DERIVEDHammer A, Gustafson LW, Christensen PN, Brondum R, Andersen B, Andersen RH, Tranberg M. Implementation of p16/Ki67 dual stain cytology in a Danish routine screening laboratory: Importance of adequate training and experience. Cancer Med. 2020 Nov;9(21):8235-8242. doi: 10.1002/cam4.3399. Epub 2020 Sep 7. PMID 32894896