About this trial
This study aims to investigate the expression of FAP by phosphor imaging in invasive vulvar squamous cell carcinoma specimens. This in vitro study will include all consecutive tumour specimens stored both in optimal cutting temperature (OCT) compound and formalin-fixed paraffin-embedded (FFPE) from patients with a first diagnosis of vulvar squamous cell carcinoma who underwent surgery at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histologically confirmed diagnosis of invasive vulvar cancer with squamous cell histotype, both from primary tumour site and excised metastatic LNs.
Availability of both FFPE and OCT stored samples from each primary tumour site and (when available) from the corresponding metastatic groin lymph nodes.
Samples stored in sufficient quantity not to be completely exhausted by their use for this study.
Optimal stored sample
Disqualifiers
None
Trial population
The specimens of patients with vulvar squamous cell carcinoma, who underwent surgery at the Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy, during the study period.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Proportion of specimens with FAP expression
Defines the proportion of VSCC specimens with expression of FAP (%).
Quantitative FAP binding
Quantitative FAP binding, measured as counts per minute (cpm)/mm2 of residual radioactivity after incubation time/washing step.
FAP binding affinity
FAP binding affinity, measured as % inhibition of specific binding plotted against the concentration of radiotracers.
Distribution of radiotracer in VSCC specimens
Distribution of radiotracer in VSCC specimens, measured as cpm/mm2 in specific regions of the specimens (e.g., hypoxic region, perivascular).
Secondary outcomes
Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Patients's Age
Probability of testing the correlation of FAP expression level (unit: digital light unit) with age (unit: years).
Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor FIGO Stage
Probability of testing the correlation of FAP expression level (unit: digital light unit) with tumor FIGO stage (adimensional).
Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Grading
Probability of testing the correlation of FAP expression level (unit: digital light unit) with tumor pathological grading 1-2 vs 3 (adimensional).
Correlating FAP Expression in Vulvar Squamous Cell Carcinoma Specimen (Derived by Phosphor Imaging With [18F]F-FAPI-74) to Tumor Pathological Histotype
Probability of testing the correlation of FAP expression level (unit: digital light unit) with tumor pathological histotype squamous vs other (adimensional).
Sponsors and contacts
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