Clinical trial NCT06852157: Evaluation of the Diagnostic and Prognostic Value of Immunohistochemical Markers in Precancerous Lesions of the Cervix
Official title: Evaluation Of The Diagnostic And Prognostic Value Of Immunohistochemical Markers In Precancerous Lesions Of The Cervix
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervix Cancer
Keywords: cervix cancer
gynaecology
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed description: Cervical cancer is the second most common malignancy in women and the most common gynaecological cancer worldwide. Numerous risk factors are associated with the development of cervical cancer; in particular, human papilloma virus (HPV) infection plays a decisive role in the development of the neoplasm. Almost all cervical cancers are caused by persistent human papilloma virus (HPV) infections.

In particular, squamous cell carcinoma accounts for about 70% of cervical cancers; its precursor is called 'cervical intraepithelial neoplasia' (CIN) or 'squamous intraepithelial lesion' (SIL) and is classified according to the degree of dysplasia. The 'CIN' classification system defines three categories: CIN1 (dysplasia limited to the lower third of the epithelium), CIN2 (dysplasia extending into the middle third of the epithelium) and CIN3 (dysplasia extending into the upper third of the epithelium). More recently, the 'CIN' system has been replaced by the 'SIL' system, which appears more reproducible and biologically relevant. The 'SIL' system reduces the categories from three to two: low grade - SIL (L - SIL, overlapping CIN1) and high grade - SIL (H - SIL, grouping CIN2 and CIN3 together).

Several diagnostic markers have been proposed, such as athanogene 3 associated with Bcl - 2 (BAG3) and others with prognostic value such as topoisomerase 2A (TOP2), minichromosome maintenance protein 2 (MCM 2), Ki-67, P16INK4, P-53 associated with cervical cancer. However, there is no strong evidence for the association of these markers with precancerous lesions.

Our study therefore aims to investigate the diagnostic and prognostic value of Bcl-associated athanogene 3 - 2 (BAG3) in patients diagnosed with CIN/SIL undergoing colposcopic cervical biopsies or conization.

This clinical trial is therefore a tissue-based, diagnostic and prognostic accuracy, retrospective cohort, single-center, non-profit, pilot study and foresees that histological sections obtained at the time of initial diagnosis will be re-evaluated in blinded fashion by two pathologists regarding histological diagnosis, histotype, histological grading, lymphocytic infiltrate. They will then be subjected to immunohistochemistry according to the specific protocol for BAG3.

Eligibility criteria: 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 outcomes:
measure: Expression of BAG3
timeFrame: enrollment through study completion, an average of 1 year
Secondary outcomes:
measure: Correlation between BAG3 expression and the degree of dysplasia of cervical lesions
timeFrame: After enrollment, through study completion, an average of 1 year
measure: Evolution of bag3 expression over time
timeFrame: After enrollment, through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Paolo Casadio, MD
role: PRINCIPAL_INVESTIGATOR
References: