Clinical trial · Observational
Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma
Pilot Study to Describe the Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma
NCT07018037CI-TRIAL-00113786TTV ccRCCrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Torquetenovirus in numbers of copies/ml
- timeFrame
- 24 months
- description
- 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 (1)
- measure
- Microbiome assessment
- timeFrame
- 24 months
- description
- Microbiome will be described in terms of the type of microbial species present.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.