See and Treat in an Outpatient Setting in Women Above 45 Years With Cervical Dysplasia

NCT04298957 | Completed

• 1 other identifier: 172230
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 3

Brief Summary

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

Cervical Dysplasia; Cervical Lesion; Cervix Disease

Keywords

Cone biopsy; Colposcopy; See and treat

Outcome Measures

Primary Outcomes (4)

• Cervical intraepithelial neoplasia ≥ grade 2 (CIN2+) lesion after referral with a positive cervical screening test

  The prevalence of CIN2+ lesions in women ≥45 years included in the study

  The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.

• Concordance between cytology and histology

  Concordance between cytology, biopsies and cone biopsy in the ability to detect CIN2+ changes

  The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.

• Clearance of HPV

  Clearance rate of HPV after 6 months

  This will be available 7 months after inclusion.

• Complication rate

  Complication rate of bleeding, infection and/or stenosis

  Complication rate will be evaluated 6 months after inclusion.

Study Arms (1)

See and treat

OTHER

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.

Procedure: Cone biopsy

Interventions

Cone biopsy PROCEDURE

Cone biopsy if transformation Zone (TZ) 2 or TZ 3

See and treat

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Type 1 transformation zone (fully visible)
• Current or previous diagnosis of cervical cancer.
• Pregnancy or pregnancy wish.
• Previously cone biopsy

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (3)

Horsens Regional Hospital

Horsens, Jutland, 8700, Denmark

Location

Randers Regional Hospital

Randers, Jutland, 8930, Denmark

Location

Viborg Regional Hospital

Viborg, Jutland, 8800, Denmark

Location

Related Publications (2)

• Binderup 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 DERIVED

• Hammer 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 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Diseases

Interventions

Conization

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Line W Gustafson, MD

  Randers Regional Hospital and Aarhus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: March 6, 2020
• Study Start: March 13, 2019
• Primary Completion: June 30, 2021
• Study Completion: January 31, 2022
• Last Updated: May 18, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)