Feasibility of Sending a Direct Send HPV Self-sampling Kit to Long-term Screening Non-attenders

Sponsor

Falu Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04909281

Collaborator

(none)

741

Enrollment

Location

7.2

Actual Duration (Months)

102.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

All women in one Swedish county who had not participated in the organized screening program for at least 10 years were sent an HPV self-sampling kit. Women who were positive for HPV were referred to a gynecological examination including colposcopy and further testing according to national guidelines.

Condition or Disease	Intervention/Treatment	Phase
HPV Cervical Cancer	Diagnostic Test: Self-sampling HPV

Detailed Description

In this cohort study nested in the organized cervical screening program, all women who had not participated in the organized screening program for at least 10 years in one Swedish county were eligible. Women were identified through the screening hub register that administrates for all invitations, referrals, and monitoring of the cervical screening program. The county screening hub invites approximately 30 000 women yearly to routine screening. Those who had opted out of the screening program, undergone hysterectomy, or changed their personal identification number (PNR) were excluded. HPV self-sampling kits with instructions and invitation letters were sent from the Department of Laboratory Medicine, Falun Hospital, in batches over 4 weeks. Lists of invitees were checked against changes in the screening hub register for individuals who moved, emigrated, died, or had taken a routine screening sample before sending a kit. Samples were received and HPV-analysis was performed.

If the self-sample HPV test was negative, the woman was returned to the screening program according to routine practice. HPV-positive women were referred without triage for further investigation to a gynecologist responsible for the clinical follow-up of high-risk women. The gynecological examination included colposcopy as well as biopsies and a liquid based cytology (LBC) sample (analyzed for cytology and HPV), which are routine examinations in clinical practice according to national and international guidelines. Colposcopies were performed within 3 months of a positive self-sample. If the colposcopic examination or the cytological/histopathological results indicated high-grade squamous intraepithelial lesions (HSIL) or invasive cervical cancer, women underwent treatment by conization and/or hysterectomy according to national guidelines The Cobas® PCR Female Swab Sample Packet was used for self-sampling, as previous studies had determined that the sensitivity for HPV was high and comparable with cervical samples used in the organized screening program. The HPV analysis was performed at the Department of Laboratory Medicine, Falun Hospital using the Cobas 4800 HPV Test (Roche Molecular Systems, South Branchburg, New Jersey, USA).

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

741 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Feasibility of Sending a Direct Send HPV Self-sampling Kit to Long-term Non-attenders in an Organized Cervical Screening Program

Actual Study Start Date :

Aug 28, 2019

Actual Primary Completion Date :

Sep 3, 2019

Actual Study Completion Date :

Apr 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Long-term non-attenders in the cervical screening program All women who had not attended tthe cervical screening program in Sweden for at least 10 years were eligeble.	Diagnostic Test: Self-sampling HPV In this cohort study nested in the organized cervical screening program, all women who had not participated in the organized screening program for at least 10 years in one Swedish county were eligible.

Arm

Intervention/Treatment

Long-term non-attenders in the cervical screening program

All women who had not attended tthe cervical screening program in Sweden for at least 10 years were eligeble.

Diagnostic Test: Self-sampling HPV

Outcome Measures

Primary Outcome Measures

Histopathologically confirmed high grade cervical lesions and cervical cancer among long-trem non-attenders in the organized cervical screening program [1 year]
To evaluate the prevalence of high grade cervical lesions and cervical cancer cancer among long-term non-attenders in the organized screening program

Eligibility Criteria

Criteria

Ages Eligible for Study:

33 Years to 70 Years

Sexes Eligible for Study:

Female

Inclusion Criteria:

Women who had not participated in the organized screening program for at least 10 years

Exclusion Criteria:

Women who were hystrectomized, moved, died

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Falu Lasarett	Falun	Dalarna	Sweden	79172

Sponsors and Collaborators

Falu Hospital

Investigators

Principal Investigator: Hanna I Sahlgren, md, RCC
Principal Investigator: Miriam K Elfström, phd, RCC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanna Sahlgren, Principal Investigator, Falu Hospital

ClinicalTrials.gov Identifier:

NCT04909281

Other Study ID Numbers:

DNR 2019-02564

First Posted:

Jun 1, 2021

Last Update Posted:

Jun 1, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hanna Sahlgren, Principal Investigator, Falu Hospital

self sampling

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Jun 1, 2021