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Screening Triage and Risk Stratification

NCT05727228 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2023-02-14

No results posted yet for this study

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

Interventions

OTHER

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

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.

Sponsors & Collaborators

  • Randers Regional Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • mette tranberg, post doc · Randers Regional Hospital, Denmark

Eligibility

Min Age
23 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-27
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05727228 on ClinicalTrials.gov