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

Karolinska Institute

Status: Enrolling

Conditions: Human Papilloma Virus; Cervical Intraepithelial Neoplasia; Cervical Cancer

Treatments: Diagnostic Test: HPV testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05229679

2020-00053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180,000 estimated patients

Sex: Female

Ages: 23 to 29 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women ages 23-29 invited to screening.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

180,000 participants in 1 patient group

HPV-based screening

Experimental group

Description:

Women 23-29 invited to cervical screening will have their samples analyzed for HPV.

Treatment:

Diagnostic Test: HPV testing