Back to resultsHPV-based Screening Among Women 23-29 Years of Age
Primary Purpose
Human Papilloma Virus, Cervical Intraepithelial Neoplasia, Cervical Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
HPV testing
Sponsored by
About this trial
This is an interventional prevention trial for Human Papilloma Virus focused on measuring Organized screening, HPV vaccination, Human papilloma virus, Prevention
Eligibility Criteria
Inclusion Criteria:
- Women ages 23-29 invited to screening.
Exclusion Criteria:
- Women who do not show up for screening or do not consent.
Sites / Locations
- Region of Skåne
- Region StockholmRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HPV-based screening
Arm Description
Women 23-29 invited to cervical screening will have their samples analyzed for HPV.
Outcomes
Primary Outcome Measures
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Incidence of cervical cancer
Cervical cancer incidence in the intervention group compared to a historical control group.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05229679
First Posted
November 30, 2021
Last Updated
October 5, 2023
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT05229679
Brief Title
HPV-based Screening Among Women 23-29 Years of Age
Official Title
Evaluation of Organized Human Papilloma Virus (HPV) Screening of 23-29-year-old Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
December 31, 2038 (Anticipated)
Study Completion Date
December 31, 2038 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus, Cervical Intraepithelial Neoplasia, Cervical Cancer
Keywords
Organized screening, HPV vaccination, Human papilloma virus, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HPV-based screening
Arm Type
Experimental
Arm Description
Women 23-29 invited to cervical screening will have their samples analyzed for HPV.
Intervention Type
Diagnostic Test
Intervention Name(s)
HPV testing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of cervical cancer
Description
Cervical cancer incidence in the intervention group compared to a historical control group.
Time Frame
Measured once during 1 year, year 1.
Title
Incidence of cervical cancer
Description
Cervical cancer incidence in the intervention group compared to a historical control group.
Time Frame
Measured once during 1 year, year 2.
Title
Incidence of cervical cancer
Description
Cervical cancer incidence in the intervention group compared to a historical control group.
Time Frame
Measured once during 1 year, year 3.
Title
Incidence of cervical cancer
Description
Cervical cancer incidence in the intervention group compared to a historical control group.
Time Frame
Measured once during 1 year, year 4.
Title
Incidence of cervical cancer
Description
Cervical cancer incidence in the intervention group compared to a historical control group.
Time Frame
Measured once during 1 year, year 5.
Title
Incidence of cervical cancer
Description
Cervical cancer incidence in the intervention group compared to a historical control group.
Time Frame
Measured once during 1 year, year 6.
Title
Incidence of cervical cancer
Description
Cervical cancer incidence in the intervention group compared to a historical control group.
Time Frame
Measured once during 1 year, year 7.
Title
Incidence of cervical cancer
Description
Cervical cancer incidence in the intervention group compared to a historical control group.
Time Frame
Measured once during 1 year, year 8.
Title
Incidence of cervical cancer
Description
Cervical cancer incidence in the intervention group compared to a historical control group.
Time Frame
Measured once during 1 year, year 9.
Title
Incidence of cervical cancer
Description
Cervical cancer incidence in the intervention group compared to a historical control group.
Time Frame
Measured once during 1 year, year 10.
Secondary Outcome Measure Information:
Title
Cost-effectiveness of the new screening method
Description
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.
Time Frame
Measured once during 1 year, year 1.
Title
Cost-effectiveness of the new screening method
Description
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.
Time Frame
Measured once during 1 year, year 2.
Title
Cost-effectiveness of the new screening method
Description
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.
Time Frame
Measured once during 1 year, year 3.
Title
Cost-effectiveness of the new screening method
Description
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.
Time Frame
Measured once during 1 year, year 4.
Title
Cost-effectiveness of the new screening method
Description
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.
Time Frame
Measured once during 1 year, year 5.
Title
Cost-effectiveness of the new screening method
Description
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.
Time Frame
Measured once during 1 year, year 6.
Title
Cost-effectiveness of the new screening method
Description
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.
Time Frame
Measured once during 1 year, year 7.
Title
Cost-effectiveness of the new screening method
Description
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.
Time Frame
Measured once during 1 year, year 8.
Title
Cost-effectiveness of the new screening method
Description
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.
Time Frame
Measured once during 1 year, year 9.
Title
Cost-effectiveness of the new screening method
Description
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.
Time Frame
Measured once during 1 year, year 10.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Individuals with a cervix and with a personal ID number indicating that they are a female, are eligible.
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women ages 23-29 invited to screening.
Exclusion Criteria:
Women who do not show up for screening or do not consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joakim Dillner, MD, PhD
Phone
+46 (0) 72-468 24 60
Email
joakim.dillner@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Elfström, PhD
Phone
+46 (0) 70-381 62 77
Email
miriam.elfstrom@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joakim Dillner, MD, PhD
Organizational Affiliation
Karolinska University Hospital/Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region of Skåne
City
Lund
State/Province
Skåne
ZIP/Postal Code
221 00
Country
Sweden
Individual Site Status
Active, not recruiting
Facility Name
Region Stockholm
City
Stockholm
ZIP/Postal Code
102 39
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joakim Dillner, MD, PhD
Phone
+46 (0) 72-468 24 60
Email
joakim.dillner@ki.se
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
IPD has been discussed but a plan isn't finalized.
Learn more about this trial
HPV-based Screening Among Women 23-29 Years of Age
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