Tracking TTV viral load during first-line immunotherapy for renal cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational project recruiting patients with metastatic clear cell renal cell carcinoma who are starting first-line immunotherapy (ICI+ICI or ICI+TKI) at the Regina Elena Cancer Institute in Rome. Researchers will collect blood and stool samples at baseline, before cycle 2, after cycle 4 (first radiologic reassessment), and about 12 weeks after that, with extra blood draws if immune-related toxicity occurs. The laboratory will measure TTV viral load in collected samples and describe trends over time, comparing TTV kinetics with clinical response and radiologic reassessments. The procedures are additional to standard care and are intended solely for biomarker research.

Why it matters

Who can join: the full rules

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.

Where it's running

• "Regina Elena" National Cancer Institute
  Rome, Rome, Italy Recruiting

Study contacts

• Study coordinator: Fabio Calabrò, Doctor
• Email: fabio.calabro@ifo.it
• Phone: +39 0652666271

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.