Colposcopic Impression in a Birth Cohort Previously Eligible for HPV-vaccination

NCT04909814 | Completed

• 1 other identifier: 2018/535-31/1
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Women were invited to attend colposcopy within two-four months after a positive screening test (two consecutive screening tests indicating low-grade squamous intraepithelial lesions (LSIL) and HPV positivity or a single screening test indicating high grade squamous intraepithelial lesions (HSIL)), according to national guidelines

Conditions

HPV; Cervical Cancer

Keywords

colposcopy

Outcome Measures

Primary Outcomes (1)

• Performance of the Swedscore colposcopy scale in HPV-vaccinated women

  Positive predictive value of colposcopy for high grade lesions in HPV-vaccinated women

  1 year

Study Arms (1)

Vaccinated women with positive screening test

All women in one Swedish county taking their first screening test within the organized cervical screening program

Biological: The performance of colposcopy in vaccinated women

Interventions

The performance of colposcopy in vaccinated women BIOLOGICAL

Evaluating the performance of colpscopy in HPV vaccinated women by comparing vaccinated and unvaccinated women taking their first test within the organized screening program

Vaccinated women with positive screening test

Eligibility Criteria

• Age: 22 Years - 26 Years
• Gender Eligibility Details: Only women go through colpsocopy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women were invited to attend colposcopy within two-four months after a positive screening test (two consecutive screening tests indicating low-grade squamous intraepithelial lesions (LSIL) and HPV positivity or a single screening test indicating high grade squamous intraepithelial lesions (HSIL)), according to national guidelines

You may qualify if:

• \- HPV-vaccinated women Women taking their first test within the organized cervical screening program at age 23 Women residing in one Swedish county

You may not qualify if:

• Women who were hysterectomized, Women who died Women who moved

Sponsors & Collaborators

• Falu Hospital: lead

Study Sites (1)

Falu Lasarett

Falun, Dalarna County, 79172, Sweden

Location

Related Publications (1)

• Sahlgren HAI, Elfgren K, Sparen P, Elfstrom MK. Colposcopic performance in a birth cohort previously eligible for human papillomavirus vaccination. Am J Obstet Gynecol. 2022 May;226(5):704.e1-704.e9. doi: 10.1016/j.ajog.2021.11.1372. Epub 2021 Dec 23.

  PMID: 34954217 DERIVED

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: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 2, 2021
• Study Start: March 14, 2018
• Primary Completion: October 15, 2019
• Study Completion: December 31, 2019
• Last Updated: June 7, 2021

Record last verified: 2021-06

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)