NCT06863857Recruiting
Dual-energy SPEctral CT to Evaluate Response to First-line Therapies in Patients With Metastatic Clear Cell REnal Cancer
Dual-energy SPEctral CT to Evaluate Response to New First-line Therapies in Patients With Metastatic Clear Cell REnal Cancer and the Association of Its Parameters With Molecular Alterations
Source: ClinicalTrials.gov · Last updated 7 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the utility of dual-energy spectral computed tomography (CT) scan in monitoring treatment in patients with metastatic clear cell carcinoma of the kidney. In particular, to analyze the use of spectral CT in patients who are candidates to receive first-line treatment based on combinations of immunotherapy and molecularly targeted drugs. In particular, the parameters derived from the use of this technology and their variation during therapy will be analyzed together with some possible molecular alterations highlighted by the analysis of the tumor tissue previously taken from the patient, relating them to the response to first-line therapy with immuno-combinations.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 10 Jan 2025
- Start date
- 30 Sept 2024
- Primary completion date
- 18 Jun 2027
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Diseases
- Kidney cancer
- NCT number
- NCT06863857
What you commit to
- Study type: Observational
- Planned participants: 50
- From 30 Sept 2024 to the primary completion date, 18 Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- -None
Who the study is looking for
- Age ≥ 18 years
- Patients with histological or cytological diagnosis of clear cell RCC
- Patients with metastatic disease documented by imaging or biopsy of the secondary site
- Patients who have not had previous treatment for RCC
- Patients with an indication for first-line medical treatment based on IO+TKI, IO+IO as per clinical practice at the Medical Oncology Unit of the IRCCS University Hospital of Bologna
- Patients who have already had a dual-energy spectral total-body CT with MDC within 4 weeks of treatment initiation
- Availability of a formalin-fixed, paraffin-embedded histological block (FFPE) stored for a period \<15 years, for the execution of molecular analysis for the search for alterations of the genes ATM, BAP1, KDM5C, MET, MTOR, NF2, PBRM1, PIK3CA, PTEN, SETD2, SMARCB1, TP53, TSC1, TSC2, VHL
- Patients who knowingly express consent to participate in the study after signing the consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oncology Unit, IRCCS Azienda Ospedaliero Universitaria Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Irccs Azienda Ospedaliero - Universitario Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.