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Effectiveness of Cervical Screening in Unvaccinated, Herd Effect Protected Women (HPV400)
Sponsor: Tampere University Hospital
Summary
To identify: 1) Whether being informed infrequently results about screening is at least as a) safe and b) accurate as frequently obtaining all information from (the present combination of opportunistic/organized) cervical screening by comparing regimen results of two screening visits at the ages of 25 and 28 years (Arm A1) vs. results of one screening visit at the age of 28 years (Arm A2) in unvaccinated herd effect protected women. Unvaccinated, frequently screened women, who are not under herd effect protection will be controls (C).
Official title: Effectiveness of Cervical Screening in Unvaccinated, Herd Effect Protected Women - A Randomized Trial
Key Details
Gender
FEMALE
Age Range
25 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
14000
Start Date
2020-06-09
Completion Date
2025-12-31
Last Updated
2025-01-13
Healthy Volunteers
Yes
Interventions
Frequent information of cytological/ HPV DNA screening results
All participants will be referred to pertinent diagnosis and treatment according to local standard of care (Käypä hoito 2010) should the cytological screening results (HSIL, ASC-H, AGC-FN) or three consecutive LSIL findings at repeated control visits within 3 years indicate it. The most common screening results (ASCUS, LSIL) are, however, not convened to arm A2 participants before age 28. All cytology and HPV DNA results results are being revealed to all trial participants at age 28 at the study end.
Locations (18)
HPV-tutkimukset
Hämeenlinna, Finland
HUS
Helsinki, Finland
HPV-tutkimukset
Iisalmi, Finland
HPV-tutkimukset
Joensuu, Finland
HPV-tutkimukset
Jyväskylä, Finland
Nuorisotutkimusasema, PSHP/ Tampereen yliopisto
Kemi, Finland
Nuorisotutkimusasema, PSHP/Tampereen yliopisto
Kotka, Finland
HPV-tutkimukset
Kouvola, Finland
Nuorisotutkimusasema, PSHP; Tampereen yliopisto
Kuopio, Finland
Nuorisotutkimusasema, PSHP/ Tampereen yliopisto
Lahti, Finland
HPV-tutkimukset
Oulu, Finland
HPV-tutkimukset
Pori, Finland
HPV-tutkimukset
Porvoo, Finland
Nuorisotutkimusasema, PSHP; Tampereen yliopisto
Rauma, Finland
HPV-tutkimukset
Sastamala, Finland
HPV-tutkimukset
Seinäjoki, Finland
Nuorisotutkimusasema; PSHP/ Tamereen yliopisto
Tampere, Finland
HPV-tutkimukset
Varkaus, Finland