Clinical trial · Observational
Assessment of Bone Biomarkers for TKI Response in RCC With Bone Metastases, HRQoL and Comparison of Imaging Techniques
Study to Assess Bone Biomarkers for TKI Response in RCC Patients With Bone Metastasis and HRQoL in These Patients as Well as Comparing Whole Body MRI vs. Bone Scintigraphy and vs. CT in the Assessment of Metastatic Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective observational study to assess bone predictive biomarkers for TKI response in RCC patients with bone metastasis and HRQoL with TKI in these patients as well as the sensitivity and specificity of whole body magnetic resonance versus bone scintigraphy and versus CT in the assessment of metastatic lesions at bone level and at other sites.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- RCC patients with bone metastases
- description
- Patients will receive the standard TKI treatment for first line treatment naive metastatic RCC. Sunitinib or pazopanib as decided by the investigator.
Primary outcomes (1)
- measure
- Assess bone biomarkers in response to TKI
- timeFrame
- Every 3 months until an average of 12 months
- description
- Assess the predictive value to TKI of bone biomarkers (bone formation BAP, P1NP, OPG and osteocalcin, and bone resorption biomarkers CTX) in patients with RCC with bone metastases.
Secondary outcomes (9)
- measure
- Progression free survival
- timeFrame
- An average of 12 months
- description
- Assess the efficacy of TKI in patients with RCC with bone metastases.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of a stage IV renal cell carcinoma with confirmed presence of bone metastases, subsidiary of treatment with an TKI in first line * 18 years old or more * Life expectancy \> 12 weeks * Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0 - 2 * Capability of understanding the study and completing the numerical pain scale, diary of analgesics and Quality of Life forms * Patient who has given informed consent * Adequate renal, hepatic and hematologic functions Exclusion Criteria: * Pregnancy, breastfeeding or fertile patients who do not use adequate contraceptive methods * Non-clear cell histology * Non irradiated brains metastases * Symptomatic brain metastases * Inability to undergo any of the medical tests of the study * A history of breast cancer or melanoma. Other tumors are accepted as long as the patients has been for at least 5 years free of disease * Synchronic diagnosis of another neoplasm * Presence of an active infection * Any decompensated disease or metabolic disorder * Cardiac events or pulmonary embolism in the 12 months previous to inclusion
References
Publications (0)
Data not yet available