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Completed

NCT Number: NCT03177863

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

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.

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Key information

Conditions

Age range

25 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Södra Älvsborgs Sjukhus, Borås, Sweden

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About this study

Available in Swedish

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CIN 2
  • Written consent

Exclusion criteria

  • CIN (any grade) not resolved
  • Former treatment of CIN
  • Immunomodulating medication
  • Pregnancy (at start of study)

Treatment and study plan

Expectancy

Procedure

Clinical monitoring. See arm description

Primary outcomes

  1. Proportion of regress

    Time frame: 24 months from date of visit when CIN2 was diagnosed

    Proportion of women with CIN2 at inclusion who will regress to CIN1 or no evidence of disease

Secondary outcomes

  1. Proportion of regress for women with HPV16

    Time frame: Proportion of women with CIN2 at inclusion who will regress to CIN1 or no evidence of disease

    Proportion of women with CIN2 and HPV 16 at inclusion who will regress to CIN1 or no evidence of disease

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Acronym: EXCIN2

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 6, 2017
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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