Renal Cell CarcinomaTTV ccRCCNCT07018037
Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma
An observational study of Renal Cell Carcinoma, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jan 2025to 29 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic clear cell renal cell carcinoma starting first-line immunotherapy
Who may be able to join
- 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.
Who cannot join
- Previous neoplasms;
- Previous antineoplastic treatments;
- Previous steroid treatments;
- Active viral infections (e.g., HCV, HIV, etc.);
- Lack of autonomy in adhering to study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, Rome, 00144
Fabio Calabrò, +39 0652666271, fabio.calabro@ifo.it
About this study
Official title: Pilot Study to Describe the Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma
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.
Read the detailed description
The study involves the prospective recruitment of patients with metastatic clear cell renal cell carcinoma who begin a first line of treatment with immunotherapy at the UOC of Medical Oncology 1 of the Regina Elena Cancer Institute in Rome. Participants will undergo the following extra-clinical procedures and provided for by the protocol:
- Explanation, reading and signing of the informed consent;
- Performing a blood sample (approximately 7 ml);
- Collection of fecal material at different timepoints. It should be noted that the procedures necessary for conducting the study will not affect the diagnostic and therapeutic process of the patients and will only have research purposes.
The biological material collected, appropriately labeled, processed at the reference laboratories, where it will be used to perform the planned analyses. Blood and/or stool samples will be collected at different timepoints:
- Time zero (T0): before the start of therapy (blood and stool)
- C2 (T1): before the start of cycle 2 (blood)
- C4 (T2): after cycle 4, i.e. coinciding with the first radiological reassessment (blood and stool)
- 22W or 19W (T3): after 12 weeks from C4 i.e. coinciding with the radiological reassessments (blood and stool), i.e. at the last timepoint of this study.
Additional blood sampling will be performed in the case of immune-related toxicity (≥ G2 according to CTCAE) requiring steroid administration.
An additional sampling, as assessed by the investigating physician, will be collected at the time of disease progression (PD) (T4).
For each patient included in the study, the following data will be collected (obtained from the clinical documentation from the analyses conducted): personal/socio-demographic data (year of birth, sex, gender), complete histology and date of first diagnosis, surgical treatments, clinical data (e.g., laboratory tests), clinical data relating to the treatment (start and end date of each therapy with number of cycles administered, response to treatment, date of disease progression), date and location of each disease progression, patient status, date of last available follow-up, date of any death, data obtained from the analyses carried out within the present project.
- Conditions
- Renal Cell Carcinoma
- Keywords
- Torquetenovirus (TVV)
- Medical subject headings
- Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
Microbiome assessment
Microbiome will be described in terms of the type of microbial species present.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start29 Jan 2025
- Primary completion29 Jan 2026
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018037
- Sponsor's protocol ID
- RS289/IRE/25
- Acronym
- TTV ccRCC
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Describe the Role of TTV During First-line Immunotherapy Treatment in Patients With Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07018037
- Acronym / sponsor ID
- TTV ccRCC / RS289/IRE/25
- Conditions
- Renal Cell Carcinoma
- Keywords
- Torquetenovirus (TVV)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 29 Jan 2026 (actual)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study involves the prospective recruitment of patients with metastatic clear cell renal cell carcinoma who begin a first line of treatment with immunotherapy at the UOC of Medical Oncology 1 of the Regina Elena Cancer Institute in Rome. Participants will undergo the following extra-clinical procedures and provided for by the protocol:
- Explanation, reading and signing of the informed consent;
- Performing a blood sample (approximately 7 ml);
- Collection of fecal material at different timepoints. It should be noted that the procedures necessary for conducting the study will not affect the diagnostic and therapeutic process of the patients and will only have research purposes.
The biological material collected, appropriately labeled, processed at the reference laboratories, where it will be used to perform the planned analyses. Blood and/or stool samples will be collected at different timepoints:
- Time zero (T0): before the start of therapy (blood and stool)
- C2 (T1): before the start of cycle 2 (blood)
- C4 (T2): after cycle 4, i.e. coinciding with the first radiological reassessment (blood and stool)
- 22W or 19W (T3): after 12 weeks from C4 i.e. coinciding with the radiological reassessments (blood and stool), i.e. at the last timepoint of this study.
Additional blood sampling will be performed in the case of immune-related toxicity (≥ G2 according to CTCAE) requiring steroid administration.
An additional sampling, as assessed by the investigating physician, will be collected at the time of disease progression (PD) (T4).
For each patient included in the study, the following data will be collected (obtained from the clinical documentation from the analyses conducted): personal/socio-demographic data (year of birth, sex, gender), complete histology and date of first diagnosis, surgical treatments, clinical data (e.g., laboratory tests), clinical data relating to the treatment (start and end date of each therapy with number of cycles administered, response to treatment, date of disease progression), date and location of each disease progression, patient status, date of last available follow-up, date of any death, data obtained from the analyses carried out within the present project.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic clear cell renal cell carcinoma starting first-line immunotherapy
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Previous neoplasms;
- Previous antineoplastic treatments;
- Previous steroid treatments;
- Active viral infections (e.g., HCV, HIV, etc.);
- Lack of autonomy in adhering to study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Torquetenovirus in numbers of copies/ml
Time frame: 24 months
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.
1 secondary outcome
Microbiome assessment
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Regina Elena Cancer Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Calabrò, Doctor (+39 0652666271, fabio.calabro@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Torquetenovirus in numbers of copies/ml (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.