HPV-based Screening Among Women 23-29 Years of Age

Cervical Cancer Clinical Trial

Official title:

Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05229679
• Other study ID #: 2020-00053
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: December 31, 2038

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: Joakim Dillner, MD, PhD
• Phone: +46 (0) 72-468 24 60
• Email: joakim.dillner[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology.

Description:

The aim is to investigate whether primary HPV analysis in the organized cell sampling program for women in the age group 23-29 provides higher cancer protection compared to the current method where cell samples are primarily analyzed with cytology. In this study, all women in the age group 23-29 in the Stockholm and Skåne Region of Sweden will participate. Age is defined by year of birth. For 2020, women born 1991-1997 are included. Sampling and collection of samples is the same as for cytology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180000
• Est. completion date: December 31, 2038
• Est. primary completion date: December 31, 2038
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 29 Years

Eligibility

Inclusion Criteria:

• Women ages 23-29 invited to screening.

Exclusion Criteria:

• Women who do not show up for screening or do not consent.

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Human Papilloma Virus
• Papilloma
• Uterine Cervical Dysplasia

Intervention

Diagnostic Test:
• HPV testing
All women age 23-29 resident in the pilot counties will be invited to HPV screening as of the study start date. The same invitation as currently used for women aged 30 and upwards will be used. This information clearly states that it is possible to opt out of the program and that data from the screening program will be collected to regional and national quality registers who will systematically evaluate the quality of the care. At the screening station, the samples are collected identically regardless of primary screening test used - there is no change in the procedures used neither for the woman or for the midwives taking the sample. HPV testing will be performed using the same purchased, CE-marked and accredited HPV screening platforms as currently used for women aged 30 and upwards. The cytology is according to the liquid-based cytology method.

Locations

Country	Name	City	State
Sweden	Region of Skåne	Lund	Skåne
Sweden	Region Stockholm	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 1.
Primary	Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 2.
Primary	Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 3.
Primary	Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 4.
Primary	Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 5.
Primary	Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 6.
Primary	Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 7.
Primary	Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 8.
Primary	Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 9.
Primary	Incidence of cervical cancer	Cervical cancer incidence in the intervention group compared to a historical control group.	Measured once during 1 year, year 10.
Secondary	Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 1.
Secondary	Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 2.
Secondary	Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 3.
Secondary	Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 4.
Secondary	Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 5.
Secondary	Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 6.
Secondary	Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 7.
Secondary	Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 8.
Secondary	Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 9.
Secondary	Cost-effectiveness of the new screening method	Cost-effectiveness of HPV-based screening among women 23-29 as compared to cytology-based screening in the same age group. Cost data will be collected from the economy system used for the administration of the study, and compared to previous cost data.	Measured once during 1 year, year 10.