Clinical trial NCT04298957: See and Treat in an Outpatient Setting in Women Above 45 Years With Cervical Dysplasia
Official title: See and Treat in an Outpatient Setting in Women Above 45 Years With Cervical Dysplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Dysplasia
Cervical Lesion
Cervix Disease
Keywords: Cone biopsy
Colposcopy
See and treat
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 109
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
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.
measure: Concordance between cytology and histology
timeFrame: The histological diagnose from the Pathological Department will be available 8 weeks after inclusion.
measure: Clearance of HPV
timeFrame: This will be available 7 months after inclusion.
measure: Complication rate
timeFrame: Complication rate will be evaluated 6 months after inclusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
state: Jutland
city: Randers
country: Denmark
facility: Randers Regional Hospital
state: Jutland
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
state: Jutland
Study officials:
affiliation: Randers Regional Hospital and Aarhus University
name: Line W Gustafson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.