Tracking TTV viral load during first-line immunotherapy for renal cell carcinoma
Pilot Study to Describe the Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma
Regina Elena Cancer Institute · NCT07018037
This project will test whether changes in torquetenovirus (TTV) levels in blood and stool can help predict how people with metastatic clear cell renal cell carcinoma respond to first-line immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Rome) |
| Trial ID | NCT07018037 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with a histologic diagnosis of metastatic clear cell renal cell carcinoma who are treatment-naive and about to start first-line immunotherapy, able to give informed consent and provide blood and stool samples, are ideal candidates.
Not a fit: Patients with prior systemic antineoplastic treatment, non–clear cell histology, active viral infections, recent steroid use, or inability to comply with sample collection are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, this could provide a simple viral-load biomarker to help predict who is more likely to respond to first-line immunotherapy and guide monitoring.
How similar studies have performed: Some prior work in transplant and other immunotherapy settings has linked TTV levels to immune competence, but using TTV as a predictive biomarker in first-line renal cell carcinoma is largely exploratory and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (RECRUITING)
Study contacts
- Study coordinator: Fabio Calabrò, Doctor
- Email: fabio.calabro@ifo.it
- Phone: +39 0652666271
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Renal Cell Carcinoma, Torquetenovirus