NCT05215470Active, not recruitingPhase 2
CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy
CLARA: Characterization of Somatic and Germline Mechanisms That Impact the Immunotherapy Treatment and Prognosis of Patients With Renal Cancer
Source: ClinicalTrials.gov · Last updated 3 Jul 2024
Brief summary (registry, in English)
The study is studying the joint contribution and interactions of germline variants and somatic mutations and their impact on Renal Cell Carcinoma (RCC) development and treatment (immunotherapy).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 17 Jan 2022
- Start date
- 18 Jan 2022
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Hospital das Clínicas de Ribeirão Preto
- Diseases
- Kidney cancer
- NCT number
- NCT05215470
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 18 Jan 2022 to the primary completion date, 30 Nov 2024
- 1 site 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.
Prior treatment
- Any condition requiring systemic treatment with corticosteroids;
Other illness
- History of a known or suspected autoimmune disease;
Lab values
- Creatinine clearance \< 40mL/min;
- Alanine aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) \> 5 x ULN;
Other
- Pregnant women.
Who the study is looking for
- Renal cell carcinoma patient: histological confirmed clear cell tumor;
- First-line metastatic treatment;
- Stage IV with at least one measured lesion;
- Fresh-frozen primary tumor tissue available;
- No previous immunotherapy or tyrosine kinase inhibitor treatment;
- All International Metastatic RCC Database Consortium (IMDC) Risk Score;
- Karnofsky Performance Scale (KPS) \>=70;
- \>=18 years old.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.