NCT03177863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2021

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

4 years

First QC Date

June 2, 2017

Last Update Submit

October 24, 2022

Conditions

CIN2Therapy

Keywords

neoplasmuterine cervix

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Proportion of regress for women with HPV16

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

Study Arms (1)

Study cohort

EXPERIMENTAL

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

Interventions

ExpectancyPROCEDURE

Clinical monitoring. See arm description

Study cohort

Eligibility Criteria

Age25 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • CIN 2
  • Written consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Södra Älvsborgs Sjukhus

Borås, Sweden

Location

Kungshöjds gynekologmottagning

Gothenburg, 43350, Sweden

Location

Frölunda specialistsjukhus

Gothenburg, Sweden

Location

Skaraborgs sjukhus, kvinnokliniken

Skövde, Sweden

Location

Norra Älvsborgs sjukhus, kvinnokliniken

Trollhättan, Sweden

Location

Related Publications (8)

  • Massad LS, Einstein MH, Huh WK, Katki HA, Kinney WK, Schiffman M, Solomon D, Wentzensen N, Lawson HW; 2012 ASCCP Consensus Guidelines Conference. 2012 updated consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors. Obstet Gynecol. 2013 Apr;121(4):829-846. doi: 10.1097/AOG.0b013e3182883a34.

    PMID: 23635684BACKGROUND

  • Kyrgiou M, Mitra A, Arbyn M, Stasinou SM, Martin-Hirsch P, Bennett P, Paraskevaidis E. Fertility and early pregnancy outcomes after treatment for cervical intraepithelial neoplasia: systematic review and meta-analysis. BMJ. 2014 Oct 28;349:g6192. doi: 10.1136/bmj.g6192.

    PMID: 25352501BACKGROUND

  • Wilkinson TM, Sykes PH, Simcock B, Petrich S. Recurrence of high-grade cervical abnormalities following conservative management of cervical intraepithelial neoplasia grade 2. Am J Obstet Gynecol. 2015 Jun;212(6):769.e1-7. doi: 10.1016/j.ajog.2015.01.010. Epub 2015 Jan 9.

    PMID: 25582099RESULT

  • Ostor AG. Natural history of cervical intraepithelial neoplasia: a critical review. Int J Gynecol Pathol. 1993 Apr;12(2):186-92.

    PMID: 8463044RESULT

  • Discacciati MG, de Souza CA, d'Otavianno MG, Angelo-Andrade LA, Westin MC, Rabelo-Santos SH, Zeferino LC. Outcome of expectant management of cervical intraepithelial neoplasia grade 2 in women followed for 12 months. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):204-8. doi: 10.1016/j.ejogrb.2010.12.002. Epub 2010 Dec 28.

    PMID: 21193261RESULT

  • Guedes AC, Zeferino LC, Syrjanen KJ, Brenna SM. Short-term outcome of cervical intraepithelial neoplasia grade 2: considerations for management strategies and reproducibility of diagnosis. Anticancer Res. 2010 Jun;30(6):2319-23.

    PMID: 20651386RESULT

  • Ho GY, Einstein MH, Romney SL, Kadish AS, Abadi M, Mikhail M, Basu J, Thysen B, Reimers L, Palan PR, Trim S, Soroudi N, Burk RD; Albert Einstein Cervix Dysplasia Clinical Consortium. Risk factors for persistent cervical intraepithelial neoplasia grades 1 and 2: managed by watchful waiting. J Low Genit Tract Dis. 2011 Oct;15(4):268-75. doi: 10.1097/LGT.0b013e3182216fef.

    PMID: 21811178RESULT

  • Castle PE, Schiffman M, Wheeler CM, Solomon D. Evidence for frequent regression of cervical intraepithelial neoplasia-grade 2. Obstet Gynecol. 2009 Jan;113(1):18-25. doi: 10.1097/AOG.0b013e31818f5008.

    PMID: 19104355RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Strander

    Sahlgrenska Academy, Gothenburg University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 6, 2017

Study Start

June 12, 2017

Primary Completion

June 24, 2021

Study Completion

June 24, 2021

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(5)