The aim of this project is to descriptively explore the trend of torquetenovirus viral load TTV during therapy with immune checkpoint inhibitor ICI in these patients, to evaluate a possible role of this virus as a biomarker of response.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients over 18 years of age;
* Histological diagnosis of clear cell renal cell carcinoma;
* Evidence of advanced or metastatic disease;
* Patients diagnosed with metastatic clear cell renal cell carcinoma about to start first-line immunotherapy (ICI + ICI or ICI + TKI);
* Patients able to comply with the study procedures.
* Patients who give written informed consent personally or through a witness (study participation and data processing), before any study-specific procedure is started.
Exclusion Criteria:
* Previous neoplasms;
* Previous antineoplastic treatments;
* Previous steroid treatments;
* Active viral infections (e.g., HCV, HIV, etc.);
* Lack of autonomy in adhering to study procedures.
Primary outcome measure(s)
Torquetenovirus in numbers of copies/ml — 24 months To descriptively evaluate the trend of torquetenovirus TTV viral load measured in number of copies/milliliter using a quantitative method, i.e. a REAL TIME PCR, during treatment with immunotherapy in patients with metastatic clear cell renal cell carcinoma starting a first-line treatment.
Trial sites (1)
Facility
City
Region
Status
"Regina Elena" National Cancer Institute
Rome
Rome
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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