EXCIN2: Expectancy as Alternative to Treatment for Cervical Intraepithelial Neoplasia Grade 2 Among Women 25 - 30 Years of Age

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Unknown status

CT.gov ID

NCT03177863

Collaborator

(none)

160

Enrollment

Locations

Arm

57.6

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
CIN2 Therapy	Procedure: Expectancy	N/A

Detailed Description

Available in Swedish

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 12, 2017

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study cohort 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 Clinical monitoring. See arm description

Arm

Intervention/Treatment

Experimental: Study cohort

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

Clinical monitoring. See arm description

Outcome Measures

Primary Outcome Measures

Proportion of regress [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 Outcome Measures

Proportion of regress for women with HPV16 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

CIN 2
Written consent

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Södra Älvsborgs Sjukhus	Borås	Sweden
2	Kungshöjds gynekologmottagning	Göteborg	Sweden	43350
3	Frölunda specialistsjukhus	Göteborg	Sweden
4	Skaraborgs sjukhus, kvinnokliniken	Skövde	Sweden
5	Norra Älvsborgs sjukhus, kvinnokliniken	Trollhättan	Sweden

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden

Investigators

Principal Investigator: Strander, Sahlgrenska Academy, Gothenburg University, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Björn Strander, Senior researcher, Sahlgrenska University Hospital, Sweden

ClinicalTrials.gov Identifier:

NCT03177863

Other Study ID Numbers:

EX CIN 2 001

First Posted:

Jun 6, 2017

Last Update Posted:

Apr 4, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Björn Strander, Senior researcher, Sahlgrenska University Hospital, Sweden

neoplasm

uterine cervix

Additional relevant MeSH terms:

Cervical Intraepithelial Neoplasia

Study Results

No Results Posted as of Apr 4, 2019