Follow-up of Cell Changes in the Cervix

NCT05709730 | Active Not Recruiting

• 1 other identifier: AGC
• Study Type: observational
• Target: 885
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to follow up on cell changes detected in the cervical cancer screening program, to investigate whether they are handled with adequate quality.

Conditions

Cancer of Cervix

Outcome Measures

Primary Outcomes (1)

• cervical intraepithelial neoplasia 3 (CIN3+)

  Risk for developing CIN3+ or worse depending on HPV type

  2014-2018

Study Arms (1)

Women aged 26-80 with atypical glandular cell (AGC) cytology result

Women in the capital region of Sweden with AGC, a concomitant human papillomavirus (HPV) analysis, and a histopathology.

Diagnostic Test: HPV genotyping

Interventions

HPV genotyping DIAGNOSTIC_TEST

HPV genotyping of samples classified that were positive for "other HPV"

Women aged 26-80 with atypical glandular cell (AGC) cytology result

Eligibility Criteria

• Age: 23 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All women aged 23 years and older, residing in the Stockholm-Gotland region of Sweden who had an AGC diagnosis in a cervical cytology sample between February 17th, 2014, and December 31st, 2018. For eligibility, an HPV test result and a subsequent histopathological diagnosis is also required. HPV testing performed 40 days before or after the index sampling date is considered to indicate the HPV status of the index AGC.

You may qualify if:

• women with an AGC diagnosis between February 17, 2014 and December 31, 2018
• years old
• resident of the Stockholm-Gotland region of Sweden

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Related Publications (1)

• Norman I, Yilmaz E, Hjerpe A, Hortlund M, Elfstrom KM, Dillner J. Atypical glandular cells and development of cervical cancer: Population-based cohort study. Int J Cancer. 2022 Dec 1;151(11):2012-2019. doi: 10.1002/ijc.34242. Epub 2022 Aug 27.

  PMID: 36029205 BACKGROUND

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

• Joakim Dillner, MD PhD

  Joakim Dillner. Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: July 7, 2016
• Primary Completion: December 31, 2019
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: 2016-2023
• Access Criteria: Ethical permission

Locations

SE (1)