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CIN2EXCIN2NCT03177863

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

A study testing Expectancy in people with CIN2 and Therapy, run by Sahlgrenska University Hospital at 5 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 30 years, women only
Conditions the study is for
CIN2, Therapy
What is being tested?
Expectancy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
5 sitesSweden
Study dates
12 Jun 2017to 24 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 30 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • CIN 2
  • Written consent

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Sweden5 sites

  • Södra Älvsborgs Sjukhus

    Borås

  • Kungshöjds gynekologmottagning

    Gothenburg, 43350

  • Frölunda specialistsjukhus

    Gothenburg

  • Skaraborgs sjukhus, kvinnokliniken

    Skövde

  • Norra Älvsborgs sjukhus, kvinnokliniken

    Trollhättan

Other trials in Sweden

About this study

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

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.

Read the detailed description

Available in Swedish

Conditions
CIN2, Therapy
Being tested
Expectancy
Keywords
neoplasm, uterine cervix
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExpectancyProcedure or surgery

    Clinical monitoring. See arm description

Study groups in NCT03177863
Study groupRoleWhat they receive
Study cohortExperimentalHealthy 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
Receives: Procedure: Expectancy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of regress

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

    Measured: 24 months from date of visit when CIN2 was diagnosed

Secondary outcomes (1)

  1. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2017
  2. Study start12 Jun 2017
  3. Primary completion24 Jun 2021
  4. Study completion24 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03177863
Sponsor's protocol ID
EX CIN 2 001
Acronym
EXCIN2
Status last verified
Oct 2022
First submitted
2 Jun 2017
Last updated
26 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23635684

  • 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.

    PubMed 25352501

  • 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.

    PubMed 25582099

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

    PubMed 8463044

  • 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.

    PubMed 21193261

  • 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.

    PubMed 20651386

  • 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.

    PubMed 21811178

  • 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.

    PubMed 19104355

Questions about this trial

What is this clinical trial studying?

A study testing Expectancy in people with CIN2 and Therapy, run by Sahlgrenska University Hospital at 5 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of regress (time frame: 24 months from date of visit when CIN2 was diagnosed). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03177863, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.

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