Research Project on Reminders and Self-Sampling Can Increase Participation in Gynecology Cell Sampling - Preventive Examination Against Cervical Cancer.

NCT04061967RecruitingNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Karolinska Institutet

Enrollment

20000

Start Date

2019-08-19

Completion Date

2030-06-01

Study Type

INTERVENTIONAL

Official Title

Research Project on Reminders and Self-Sampling Can Increase Participation in Gynecology Cell Sampling - Preventive Examination Against Cervical Cancer.

Interventions

Sending of screening summon.

Conditions

Cervical CancerUterine Cervical NeoplasmUterine NeoplasmsGenital NeoplasmGenital NeoplasmFemaleUterine DiseasesGenital DiseasesFemaleNeoplasms by SiteNeoplasmsUterine Cervical Disease

Eligibility

Age Range

33 Years – 75 Years

Sex

FEMALE

Inclusion Criteria:

* Women resident in Region Skane who either: 1) have had glandular cell transformation that has not been followed-up, 2) are older than 65 years and have had cell transformation that has not been followed-up or who have not participated in screening during the last 10 years, 3) women who have not been screened for more than 15 years.

Exclusion Criteria:

* No exclusion except those who do not consent.

Outcome Measures

Primary Outcomes

Proportion of women responding to summon

Participation rate in screening after summons.

Time frame: Measured from the date of the summons until 12 months after the summons

Secondary Outcomes

Number of positive screens

Screening test results

Time frame: Measured from the date of the summons until 12 months after the summons

Rate of precursors of cancer

Cytologically and histopathologically confirmed percursors of cervical cancer.

Time frame: Measured from the date of the summons until 12 months after the summons

Rate of cancer

Histopathologically confirmed cervical cancers.

Time frame: Measured from the date of the summons until 12 months after the summons

Locations

Northern Region, Luleå, Sweden

Southern Region, Lund, Sweden

Western Region, Gothenburg, Sweden

Southeast Region, Jönköping, Sweden

Region of Stockholm-Gotland, Stockholm, Sweden

Region of Middle Sweden, Uppsala, Sweden

Linked Papers

2024-08-15

Nationwide registry‐based trial of risk‐stratified cervical screening

AbstractIn well‐screened populations, most cervical cancers arise from small groups of women with inadequate screening. The present study aims to assess whether registry‐based cancer risk assessment could be used to increase screening intensity among high‐risk women. The National Cervical Screening Registry identified the 28,689 women residents in Sweden who had either no previous cervical screening or a screening history indicating high risk. We invited these women by SMS and/or physical letter to order a free human papillomavirus (HPV) self‐sampling kit. The Swedish national HPV reference laboratory performed extended HPV genotyping and referred high‐risk HPV‐positive women to their regional gynecologist. A total of 3691/28,689 (12.9%) women ordered a self‐sampling kit and 10.0% (2853/28,689) returned a sample for testing. Participation among women who had never attended screening was low, albeit improved. Up to 22.5% of women in other high‐risk groups attended. High‐risk HPV types were detected in 8.3% of samples. High‐risk HPV‐positive women (238/2853) were referred without further triaging and severe cervical precancer or cancer (HSIL+) in histopathology were detected in 36/158 (23%) of biopsied women. Repeat invitations gave modest additional participation. Nationwide contacting of women with high risk for cervical cancer with personal invitations to order HPV self‐sampling kits resulted in high yield of detected CIN2+. Further efforts to improve risk‐stratified screening strategies should be directed to improving (i) the precision of the risk‐stratification algorithm, (ii) the convenience for the women to participate and, (iii) ensuring that screen‐positive women are followed‐up.