Trial23 - A Method Study on Cervical Screening in Women Offered HPV-vaccination as Girls

NCT03049553 | Unknown

• 1 other identifier: 102-2793/15-3000
• Study Type: interventional
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief Summary

In Denmark, the first birth cohorts of women offered HPV-vaccination as girls are entering the cervical screening program. These women are expected to be better protected against cervical cancer. It has not yet been decided how to screen these women. This method study will investigate a possible screening scheme that could provide a reduced burden of screening for HPV-vaccinated birth cohorts.

Conditions

Cervical Intraepithelial Neoplasia (CIN)

Keywords

Cervical screening; Human papillomavirus (HPV); Cytology; HPV-test; Cervical intraepithelial neoplasia (CIN)

Outcome Measures

Primary Outcomes (1)

• Cumulative CIN3+ (cervical intraepithelial neoplasia grade 3 and above) in baseline screen-negative women.

  Histologically proven CIN3+ is chosen as primary outcome measure because it is the diagnostic threshold above which conization is recommended by the Danish Society of Gynecology and Obstetrics. Primary outcome will be based on intention-to-treat and per protocol analysis and stratified by region of residence. Primary HPV-testing with cytology triage every six years compared to cytology every three years will be approximated from the observed data.

  After up to 9 years follow-up (end-of-study)

Secondary Outcomes (5)

• Cumulative CIN3+ overall

  After up to 9 years follow-up (end-of-study)

• Cumulative CIN2 (cervical intraepithelial neoplasia grade 2) overall

  After up to 9 years follow-up (end-of-study)

• Cumulative CIN2 in baseline screen-negative women

  After up to 9 years follow-up (end-of-study)

• Cumulative CIN1 (cervical intraepithelial neoplasia grade 1) overall

  After up to 9 years follow-up (end-of-study)

• Cumulative CIN1 in baseline screen-negative women

  After up to 9 years follow-up (end-of-study)

Other Outcomes (6)

• Baseline CIN1

  After up to 2 years follow-up

• Baseline CIN2

  After up to 2 years follow-up

• Baseline CIN3+

  After up to 2 years follow-up

Study Arms (2)

HPV-test

OTHER

Cobas HPV-DNA test is performed on the cervical sample in addition to the routine cytology

Device: Cobas HPV-DNA test

Routine

NO INTERVENTION

Screening with cytology as usual in the cervical screening program

Interventions

Cobas HPV-DNA test DEVICE

Cobas HPV-DNA testing device from Roche is already in standard use in the Danish screening program for purpose of triage and primary screening of women 60+. It has four signals; HPV-negative, HPV-16, HPV-18 and "other"

HPV-test

Eligibility Criteria

• Age: 23 Years - 23 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women born in 1994 living in the study area

You may not qualify if:

• None, as it is a public health trial

Sponsors & Collaborators

• University of Copenhagen: lead
• Naestved Hospital: collaborator
• Aalborg University Hospital: collaborator
• Soenderjylland Hospital: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator
• Randers Regional Hospital: collaborator

Study Sites (1)

University of Copenhagen

Copenhagen, Copenhagen K, 1014, Denmark

Location

Related Publications (3)

• Ronco G, Dillner J, Elfstrom KM, Tunesi S, Snijders PJ, Arbyn M, Kitchener H, Segnan N, Gilham C, Giorgi-Rossi P, Berkhof J, Peto J, Meijer CJ; International HPV screening working group. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet. 2014 Feb 8;383(9916):524-32. doi: 10.1016/S0140-6736(13)62218-7. Epub 2013 Nov 3.

  PMID: 24192252 BACKGROUND

• Dillner J, Rebolj M, Birembaut P, Petry KU, Szarewski A, Munk C, de Sanjose S, Naucler P, Lloveras B, Kjaer S, Cuzick J, van Ballegooijen M, Clavel C, Iftner T; Joint European Cohort Study. Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study. BMJ. 2008 Oct 13;337:a1754. doi: 10.1136/bmj.a1754.

  PMID: 18852164 BACKGROUND

• Thamsborg LH, Andersen B, Larsen LG, Christensen J, Johansen T, Hariri J, Christiansen S, Rygaard C, Lynge E. Danish method study on cervical screening in women offered HPV vaccination as girls (Trial23): a study protocol. BMJ Open. 2018 May 26;8(5):e020294. doi: 10.1136/bmjopen-2017-020294.

  PMID: 29804060 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Elsebeth Lynge, Professor

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 10, 2017
• Study Start: February 1, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)