Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
24 months

Secondary outcomes

1

Microbiome assessment

Microbiome will be described in terms of the type of microbial species present.

Time frame
24 months

Other outcomes

Sponsors and contacts

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