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

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT04298957

Collaborator

(none)

109

Enrollment

Locations

Arm

34.7

Actual Duration (Months)

36.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Dysplasia Cervical Lesion Cervix Disease	Procedure: Cone biopsy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 13, 2019

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Procedure: Cone biopsy Cone biopsy if transformation Zone (TZ) 2 or TZ 3

Arm

Intervention/Treatment

Other: 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.

Procedure: Cone biopsy

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

Outcome Measures

Primary Outcome Measures

Cervical intraepithelial neoplasia ≥ grade 2 (CIN2+) lesion after referral with a positive cervical screening test [The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.]
The prevalence of CIN2+ lesions in women ≥45 years included in the study
Concordance between cytology and histology [The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.]
Concordance between cytology, biopsies and cone biopsy in the ability to detect CIN2+ changes
Clearance of HPV [This will be available 7 months after inclusion.]
Clearance rate of HPV after 6 months
Complication rate [Complication rate will be evaluated 6 months after inclusion.]
Complication rate of bleeding, infection and/or stenosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Horsens Regional Hospital	Horsens	Jutland	Denmark	8700
2	Randers Regional Hospital	Randers	Jutland	Denmark	8930
3	Viborg Regional Hospital	Viborg	Jutland	Denmark	8800