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

NCT06852157 | Not Yet Recruiting

• 1 other identifier: cervix-IHC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cervix cancer; gynaecology

Outcome Measures

Primary Outcomes (1)

• Expression of BAG3

  Expression of BAG3 in patients diagnosed with precancerous lesions of the cervix

  enrollment through study completion, an average of 1 year

Secondary Outcomes (2)

• Correlation between BAG3 expression and the degree of dysplasia of cervical lesions

  After enrollment, through study completion, an average of 1 year

• Evolution of bag3 expression over time

  After enrollment, through study completion, an average of 1 year

Study Arms (1)

Patients diagnosed with precancerous lesions of the cervix CIN/SIL

OTHER

Patients diagnosed with precancerous lesions of the cervix CIN/SIL undergoing diagnostic biopsy/uterine conization since January 2000

Diagnostic Test: Tissue, diagnostic and prognostic accuracy

Interventions

Tissue, diagnostic and prognostic accuracy DIAGNOSTIC_TEST

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.

Patients diagnosed with precancerous lesions of the cervix CIN/SIL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Histocompatibility Testing; Diagnosis

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)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Investigative Techniques; Immunologic Techniques

Study Officials

• Paolo Casadio, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Casadio, MD

CONTACT

+390512144411; paolo.casadio@aosp.bo.it

Giulia Borghese, MD

CONTACT

giulia.borghese@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: February 28, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

IT (1)