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

NCT04909281 | Completed

• 1 other identifier: DNR 2019-02564
• Study Type: observational
• Target: 741
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV; Cervical Cancer

Keywords

self sampling

Outcome Measures

Primary Outcomes (1)

• Histopathologically confirmed high grade cervical lesions and cervical cancer among long-trem non-attenders in the organized cervical screening program

  To evaluate the prevalence of high grade cervical lesions and cervical cancer cancer among long-term non-attenders in the organized screening program

  1 year

Study Arms (1)

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

Interventions

Self-sampling HPV DIAGNOSTIC_TEST

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.

Long-term non-attenders in the cervical screening program

Eligibility Criteria

• Age: 33 Years - 70 Years
• Gender Eligibility Details: Only women get cervical cancer
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women who had not participated in the organized screening program for at least 10 years in 1 Swedish county

You may qualify if:

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

You may not qualify if:

• \- Women who were hystrectomized, moved, died

Sponsors & Collaborators

• Falu Hospital: lead

Study Sites (1)

Falu Lasarett

Falun, Dalarna County, 79172, Sweden

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Hanna I Sahlgren, md

  RCC

  PRINCIPAL INVESTIGATOR

• Miriam K Elfström, phd

  RCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 1, 2021
• Study Start: August 28, 2019
• Primary Completion: September 3, 2019
• Study Completion: April 4, 2020
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 years
• Access Criteria: Contact principal investigator

Locations

SE (1)