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Starting soon Not applicable

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

NCT06852157 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-02
Last updated
2025-02-28

Condition(s) studied

Cervix Cancer

Investigational drug(s) / intervention(s)

Tissue, diagnostic and prognostic accuracy

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.

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with a diagnosis of CIN/SIL undergoing cervical biopsy/concussion whose tissue sample is archived at the Operative Unit of Pathological Anatomy and Histology * Obtaining written informed consent for the use of biological samples * Patients aged 18 years and over Exclusion Criteria: none

Primary outcome measure(s)

  • Expression of BAG3 — enrollment through study completion, an average of 1 year
    Expression of BAG3 in patients diagnosed with precancerous lesions of the cervix

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06852157 on ClinicalTrials.gov ↗ ← All trials in Italy