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Evaluation of the Diagnostic and Prognostic Value of Immunohistochemical Markers in Precancerous Lesions of the Cervix

NCT06852157 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-02-28

No results posted yet for this study

Summary

The study aims to evaluate the expression of certain proteins and their diagnostic and prognostic value in precancerous lesions of the cervix.

Conditions

  • Cervix Cancer

Interventions

DIAGNOSTIC_TEST

Tissue, diagnostic and prognostic accuracy

The clinical data and histological samples of patients with a diagnosis of CIN/SIL on cervical biopsies or conization (performed as required by the normal procedure) will be consecutively acquired from all those taken at the Operative Unit of Gynaecology and Physiopathology of Human Reproduction starting from January 2000 and stored at the Operative Unit of Pathological Anatomy and Histology. Samples fixed in neutral buffered formalin and paraffin added at 50°C will be analysed by repeating histological examination and performing immunohistochemistry for BAG3. All analyses will be performed blinded to the clinical data of the patients and the results of the original examinations. No patients will be examined ex novo, as only paraffin-embedded tissue samples obtained at the time of the initial diagnosis will be analysed.

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Paolo Casadio, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2025-02-28
Completion
2026-02-28

Countries

  • Italy

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 NCT06852157 on ClinicalTrials.gov