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

NCT07018037 | Recruiting

• 1 other identifier: RS289/IRE/25
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Renal Cell Carcinoma

Keywords

Torquetenovirus (TVV)

Outcome Measures

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.

  24 months

Secondary Outcomes (1)

• Microbiome assessment

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic clear cell renal cell carcinoma starting first-line immunotherapy

You may qualify if:

• 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.

You may not qualify if:

• Previous neoplasms;
• Previous antineoplastic treatments;
• Previous steroid treatments;
• Active viral infections (e.g., HCV, HIV, etc.);
• Lack of autonomy in adhering to study procedures.

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples and stool samples

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Fabio Calabrò, Doctor

CONTACT

+39 0652666271; fabio.calabro@ifo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: January 29, 2025
• Primary Completion: January 29, 2026
• Study Completion (Estimated): January 29, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

IT (1)