Evaluation of the Diagnostic and Prognostic Value of Immunohistochemical Markers in Precancerous Lesions of the Cervix
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- What is being studied
- The protocol lists: Tissue, diagnostic and prognostic accuracy.
- Who it may be relevant to
- Registry conditions: Cervix Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation Of The Diagnostic And Prognostic Value Of Immunohistochemical Markers In Precancerous Lesions Of The Cervix
Overview
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 More recently, the 'CIN' system has been replaced by the 'SIL' system, which appears more reproducible and biologically relevant.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.
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 his
Primary outcome measures
- Expression of BAG3 [Time frame: enrollment through study completion, an average of 1 year]
Secondary outcome measures (2)
- Correlation between BAG3 expression and the degree of dysplasia of cervical lesions [Time frame: After enrollment, through study completion, an average of 1 year]
- Evolution of bag3 expression over time [Time frame: After enrollment, through study completion, an average of 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06852157 · cervix-IHC