MedTrace Logo

Biomarkers Predictive for Cervical Intraepithelial Neoplasia Grade 2 (CIN2) Evolvement

NCT05049252 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-12-07

No results posted yet for this study

Summary

Introduction Cervical intraepithelial neoplasia CIN1 (low grade), CIN2 (moderate grade), CIN3 (severe grade) defines cervical precancer lesions derived from the squamous epithelial cell line. CIN2, represents a heterogenic phenotype expression of both CIN1-like and CIN3-like evolving lesions with different risk of progression. The CIN2 diagnosis has low reproducibility, and current diagnostic tools do not allow for risk-stratification of CIN2.

Risk-profiling is important, to enable targeted management of women with CIN2 at first incidence (surgery or active surveillance) and to avoid risk of over- or undertreatment.

Preliminary studies show, that the novel tissue biomarker HPV E4 has potential to discriminate CIN1-like (HPV E4 positive) from CIN3-like (HPV E4 negative) evolving CIN2 lesions, suggesting that the biomarker could be vauable for risk-stratification of CIN2.

Aim To examine the potential of the HPV E4 biomarker in predicting risk of CIN2 evolvement.

Materials and Methods Design: Historical cohort study. Study population: N=500 women, 23-40 years of age with a record of incidental CIN2 diagnosis between \[2000-2010\] in the Danish Pathology Data Bank at Aarhus University Hospital, Region of Central Denmark. All women are defined as managed by active surveillance (i.e. no surgical treatment within 4 months after first CIN2 diagnosis).

Exposure: HPV E4 positive vs HPV E4 negative intraepithelial reaction. Outcome: Regression (normal, CIN1) vs non-regression (CIN2, CIN3, cervical cancer).

Statistical model: Linear regression model (RR (95%CI)).

Perspectives: HPV E4 may act as significant predictor for CIN2 evolvement, and reliable marker for risk-assessment of CIN2. This will be valuable in the clinical management of women with CIN2, enabling to discriminate women, who would most likely regress and could be manged by active surveillance vs women in risk of progression or persistence, who could benefit of immediate surgical treatment.

Conditions

  • Cervical Intraepithelial Neoplasia Grade 2 (CIN2)

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • DDL Diagnostic Laboratory

    collaborator UNKNOWN

  • University of Cambridge

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Virginia

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Eligibility

Min Age
23 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Companies

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 NCT05049252 on ClinicalTrials.gov