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

ConditionCervix Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients diagnosed with precancerous lesions of the cervix CIN/SILOther 1 intervention

Trial outcomes

Primary outcomes

1

Expression of BAG3

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

Time frame
enrollment through study completion, an average of 1 year

Secondary outcomes

1

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

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

Time frame
After enrollment, through study completion, an average of 1 year
2

Evolution of bag3 expression over time

Evolution of BAG3 expression over time in patients with cervical biopsies/concussions afterwards

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: