Effectiveness of Cervical Screening in HPV Vaccinated Women (HPV-004)

Tampere University

Status: Active, not recruiting

Conditions: Cervical Intraepithelial Neoplasia Grade 2/3

Treatments: Other: Cytological screening in A1 and A3

Study type: Interventional

Funder types: Other

Identifiers

NCT02149030

HPV-004

Details and patient eligibility

About

The main objective of the study is to identify whether or not being informed infrequently results about screening is: 1) At least as safe and accurate as frequently obtaining all information from the present combination of opportunistic/organized cervical screening by comparing regimen results of three screening visits at the ages of 22, 25 and 30 years (Arm A1) vs. results of one screening visit at the age of 30 years (Arm A2) in Human papillomavirus (HPV) vaccinated young women.

Full description

Altogether 16.500 1992-1995 born women vaccinated with the bi-valent human papillomavirus type 16 and 18 (HPV16/18) vaccine as adolescents either at the age of 12 to 15 or at the age of 18 will be invited to an effectiveness trial at the age of 22 years, and randomized into Arms A1 and A2, and A3, respectively.

Cervical samples and cervico-vaginal self-samples rinsed in first-void urine will be analysed for HPV and C. trachomatis DNA with MGP primer system followed by MALDITOF mass spectrometry on the SEQUENOM platform (HPV) and the Abbott™ PCR (Chlamydia trachomatis), respectively.

With assumed >50% participation the trial has 80% power to show non-inferiority of the infrequent vs. the frequent screening information.

A one-way (participant) blinded interim analysis among the 1992-born study participants in A1 and A3 arms, who have attended the 2nd study visit at the age of 25 years, will be performed in 2017 for assuring no statistically significant differences in the cervical intraepithelial neoplasia grade 2/3 (CIN2/CIN3) incidences of the two arms.

At the study end testing the null hypotheses of no difference in the incidence of the CIN2/3 end-points between the A1 and A2 intervention arms will be done using the Mantel-Haenszel one degree of freedom chi-square statistics.

Enrollment: 6,958 patients

Sex: Female

Ages: 22 to 22 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• HPV 16/18 vaccinated. Born 1992-1995.

Exclusion criteria

• Immunocompromising disease. HPV 6/11/16/18 vaccination.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6,958 participants in 3 patient groups

A1

Active Comparator group

Description:

A1) Cytological screening in A1 and A3. Frequent information of screening results for cytology and/or HPV DNA at the ages of 22 (cytology only), 25 and 30.

Treatment:

Other: Cytological screening in A1 and A3

A2

No Intervention group

Description:

A2) infrequent information of screening results, only at the age 30 years.

A3

Other group

Description:

A3) Cytological screening in A1 and A3. With at least 1000 participants is enrolled for interim safety analysis when the 1992 birth cohort is 25 years of age and cytology results are being revealed.

Treatment:

Other: Cytological screening in A1 and A3