About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
Previous neoplasms;
Previous antineoplastic treatments;
Previous steroid treatments;
Active viral infections (e.g., HCV, HIV, etc.);
Trial population
Patients with metastatic clear cell renal cell carcinoma starting first-line immunotherapy
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Torquetenovirus in numbers of copies/ml
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.
Secondary outcomes
Microbiome assessment
Microbiome will be described in terms of the type of microbial species present.
Sponsors and contacts
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