Expectancy as Alternative to Treatment for Cervical Intraepithelial Neoplasia Grade 2 Among Women 25 - 30 Years of Age

Study Overview
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Brief Summary
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In the Swedish organised cervical screening program precursors of cervical cancer are detected and treated. Most precursor lesions detected by screening heal spontaneously. Those who progress do it slowly. There are three levels from light; CIN1, moderate; CIN2 to severe; CIN3. Women with CIN3 are always treated, regardless of age, according to current clinical guidelines. Women with CIN2 who are below the age of 25 years are offered active expectance for up to two years because there is good evidence that they will spontaneously heal their lesions (regression) in 40-70% of the cases during that time. Method of treatment is today an excisional procedure of the cervix most often by Large loop excision of the transformation zone (LLETZ/LEEP) Treatment increases the risk of premature birth in a future pregnancy. In 2015 about 1800 excisional procedures of the transformation zone of the cervix were performed in the Västra Götalands regionen (VGR) om Sweden. The average age of first-time mothers in Sweden is rising and in 2014 it was 29 years. Postponed childbearing raises the question whether it is possible to refrain from surgery even for the group of women over 25 years old, with proven CIN2. Existing studies suggest that cure of CIN2 in the age group of and above 25 takes place in the same extent as under 25 years of age.There is lack of evidence concerning clinical follow-up. In a prospective multicenter clinical cohort study (observational study) with careful monitoring, the investigators will examine what proportion of CIN2 changes regress spontaneously within two years in women, 25-30 years old, and if human papillomavirus (HPV) type 16 may can be a marker for poor regression in this group. Instead of LLETZ, active expectance is offered to women this age with CIN2 in five gynecological clinics in VGR. The study protocol includes gynecologist visits every 6 months for two years, including cytology, colposcopy and directed biopsies of the cervix. Power calculation shows 160 women needs to be included, which is expected to occur within one year from the start.

Detailed Description
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Available in Swedish

Official Title
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Expectancy as Alternative to Treatment for Cervical Intraepithelial Neoplasia Grade 2 Among Women 25 - 30 Years of Age. A Multicenter Clinical Study

Conditions
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CIN2, Therapy

Intervention / Treatment
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* Procedure: Expectancy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CIN 2 Written consent Exclusion Criteria: CIN (any grade) not resolved Former treatment of CIN Immunomodulating medication Pregnancy (at start of study)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study cohort<br>Healthy women 25 - 30 years of age with CIN2 who consent to inclusion and with no former history of CIN (any grade). The intervention is expectancy with clinical visits every 6 months. Women will leave study cohort if found with total regression (no CIN) or CIN3 | Procedure: Expectancy<br>* Clinical monitoring. See arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of regress | Proportion of women with CIN2 at inclusion who will regress to CIN1 or no evidence of disease | 24 months from date of visit when CIN2 was diagnosed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of regress for women with HPV16 | Proportion of women with CIN2 and HPV 16 at inclusion who will regress to CIN1 or no evidence of disease | Proportion of women with CIN2 at inclusion who will regress to CIN1 or no evidence of disease | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neoplasm, uterine cervix