Screening Triage and Risk Stratification

NCT05727228 | Recruiting

• 1 other identifier: 2704
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

• To investigate the performance of cytology, extended genotyping, p16/Ki67 dual stain cytology, DNA methylation and viral load as triage markers in post-menopausal HPV-screen-positive women aged 50-64 years in the organized screening program to predict the risk of developing CIN2+. (work package 1)
• To investigate the performance of cytology, extended genotyping, p16/Ki67 dual stain cytology, DNA methylation and viral load six months after cervical excision to predict the long-term risk of residual/recurrent CIN2+ lesions among women aged 23-64 (work-package 2)

Conditions

Cervix Cancer; HPV Testing; Postmenopausal Women

Keywords

mass screening; triage biomarkers

Outcome Measures

Primary Outcomes (4)

• The number of women with CIN2+ diagnosed in either cervical biopsies or cone biopsy

  The detection of underlying CIN2 or worse

  at baseline ( within 3 months after index sample)

• The number of women with CIN2+ diagnosed in either cervical biopsies or cone biopsy

  The detection of underlying CIN2 or worse

  at follow-up ( 1.5 years after index sample)

• The number of women with CIN3+ diagnosed in either cervical biopsies or cone biopsy

  The detection of underlying CIN3 or worse

  at baseline ( within 3 months after index sample)

• The number of women with CIN3+ diagnosed in either cervical biopsies or cone biopsy

  The detection of underlying CIN3 or worse

  at follow-up (1.5 years after index sample)

Secondary Outcomes (4)

• Clinical accuracy (sensitivity and specificity of each triage marker and in different combinations)

  at baseline (within 3 months after index sample)

• Clinical accuracy (sensitivity and specificity of each triage marker and in different combinations)

  at follow-up (1.5 years after index sample)

• HPV genotype distribution

  at baseline (within 3 months after index sample)

• DS positivity rate

  at baseline (within 3 months after index sample)

Interventions

cytology, p16/ki67 dual stain cytology (DS), extended genotyping, DNA methylation, viral load, OTHER

p16/Ki67 dual stain cytology, extended genotyping and DNA methylation will be performed from the residual cell-pellet from the HPV-positive screening samples. If no cytology-triage testing is performed as a part of the screening algorithm, a cytology will be performed at inclusion. If any residual material is left after DS, extended genotyping and DNA methylation, it will be stores at -80 degrees for future purposes.

Eligibility Criteria

• Age: 23 Years - 64 Years
• Gender Eligibility Details: This study is focused on cervical cancer screening and as only women had a cervix, only women will be included in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women aged 50-65 who have been tested HPV-screen positive Women aged 23-64 who undergo test-of-cure or follow-up test after LEEP

You may qualify if:

• HPV-screen-positive (aged 50-64)
• Women who undergo test-of-cure (i.e. HPV and cytology) six months after LEEP in Central Denmark Region (aged 23-64)
• Women who undergo follow-up test (i.e. HPV and cytology) 12 months after LEEP
• A valid cytology-triage result (aged 23-64)

You may not qualify if:

• Listed in the registry as a person who have rejected to participate in research
• Invalid cytology and HPV result six months after LEEP
• No residual material available

Sponsors & Collaborators

• University of Aarhus: lead
• Randers Regional Hospital: collaborator

Study Sites (1)

Department of Pathology

Randers, Central Jutland, 8930, Denmark

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cytological Techniques; DNA Methylation; Viral Load

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Methylation; Alkylation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Genetic Phenomena; Microbiological Techniques; Virus Physiological Phenomena; Microbiological Phenomena

Study Officials

• mette tranberg, post doc

  Randers Regional Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mette tranberg, post doc

CONTACT

40113676; mettrani@rm.dk

Line Winther Gustafson, MD

CONTACT

+4578420264; Line.Winther@skejby.rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: post doc, PhD

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 14, 2023
• Study Start: February 27, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

DK (1)