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

NCT ID: NCT04298957

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-13
• Study Completion Date: 2022-01-31

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.

Detailed Description

In Denmark, 370 women are diagnosed with cervical cancer every year and approximately 100 women die from the disease. Young women can be protected with the HPV vaccine, but it will take decades before the vaccine has an effect on older women. Women who are HPV positive have a risk of developing severe dysplasia of 25-55% within 10 years. Compared to younger women, older women are also more likely to be diagnosed with advanced-stage disease and their mortality is high. Due to retraction of the transformation zone into the cervical canal and atrophy of the mucosa the performance of colposcopy is low. Furthermore, the sensitivity of cytology decreases with age. This makes it very difficult to obtain sufficient biopsies and therefore postmenopausal women are often required to undergo colposcopy two to three times. Waiting for a final diagnosis and treatment not only has a large mental and practical impact on the women themselves, but it is also an economic burden for the health care system.

"See and treat" is a procedure that involves cervical cytology and HPV test, a colposcopy, cervical biopsies, and finally a loop electrosurgical excisional procedure by which the transformation zone is removed. This approach allows women to be diagnosed and treated in one visit.

In this project, the aim is to investigate if the implementation of "see and treat" in a gynecological outpatient clinic can optimize the diagnostics, clinical follow-up, and treatment of older women with abnormal cervical cytology or HPV-infection.

Participants Women aged ≥ 45 years with cervical dysplasia and/or a positive HPV test are referred from the general practitioner to the gynecological department.

Procedure At each inclusion site, the local project manager evaluates all the referred women for possible inclusion. Project information is sent either by e-mail or letter to eligible women. At the outpatient clinic, the eligible women will be informed about the project and asked to sign an informed consent form regarding their participation in the project.

If the eligible women agree to participate a physician in the outpatient clinic will obtain a cervical smear (i.e. cytology and Human Papillomavirus (HPV) test) and perform colposcopy and take four random biopsies. If the transformation zone (TZ) is partly visible or not visible a cone biopsy will be performed in local anesthesia (Citanest).

If the participant meet the exclusion criteria or declines to participate standard treatment will be offered (colposcopy and biopsies).

The included patients will be followed up with an HPV test after 6 months.

Conditions

Cervical Dysplasia; Cervical Lesion; Cervix Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

See and treat

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.

Group Type: OTHER

Cone biopsy

Intervention Type: PROCEDURE

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

Interventions

Cone biopsy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Line W Gustafson, MD

Role: PRINCIPAL_INVESTIGATOR

Randers Regional Hospital and Aarhus University

Locations

Horsens Regional Hospital

Horsens, Jutland, Denmark

Randers Regional Hospital

Randers, Jutland, Denmark

Viborg Regional Hospital

Viborg, Jutland, Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 40654017 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32894896 (View on PubMed)

Other Identifiers

172230

Identifier Type: -

Identifier Source: org_study_id