Clinical trial · Observational
Perspective Evaluation of Hormones Involved in Serum Phosphate Homeostasis in Patients With Metastatic Renal Cells Carcinoma or Hepatocellular Carcinoma Treated With Sorafenib (SORHORM)
Perspective Evaluation of Hormones Involved in Serum Phosphate Homeostasis in Patients With Metastatic Renal Cells Carcinoma or Hepatocellular Carcinoma Treated With Sorafenib. Multicenter Cohort Study
NCT01230697CI-TRIAL-00004073SORHORMunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
The study includes the recruitment of patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib. Multicenter cohort study. It is a prospective observational study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Sofanenib and Hypophosphatemia
- description
- Patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with Sorafenib
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration
- timeFrame
- one year
- description
- Assess the effects of sorafenib hormones involved in phosphate homeostasis
Secondary outcomes (4)
- measure
- Identify metabolic differences between renal cells cancer and hepatocarcinoma
- timeFrame
- one year
- description
- identify differences in phosphate hormone behavior between renal cells cancer and hepatocarcinoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. age over 18 years 2. Histologically documented kidney cancer or hepatocarcinoma 3. Performance status more than / equal to 2 4. Life expectancy \> 12 weeks 5. in patients with recent surgery, the wound should be completely healed before taking Sorafenib 6. required initial laboratory values: absolute neutrophil count \> 1500/ul Platelets \> 100,000/ul., Hemoglobin \> 9.0 g/dl, Creatinine, SGOT, SGPT less than 2.0 X upper limit of normal Bilirubin less than/equal to upper limit of normal(ULN) 7. Appropriate patienty compliance Exclusion Criteria: 1. myocardial infarction or significant change in anginal pattern within the last 6 months, symptomatic congestive heart failure (NYHA Class III or higher) or uncontrolled cardiac arrhythmia, 2. previous history of malignant disease with the exception of non melanoma skin cancer curatively treated, 3. significant neurologic or psychiatric diseases preventing patients to give a valid informed consent 4. Sintomatic brain metastases 5. because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded 6. patients with seizures that need medical treatment 7. History of heterologous transplantation 8. Patients with previous or active bleeding 9. Dialysis patients 10. Patients with history of primary hyperparathyroidism 11. Dysphagic patients 12. Taking more than four weeks of entry into the study of other bio-chemotherapy treatments 13. Previous treatment with Sorafenib 14. Recent (\<6 months)or concomitant treatment with biphosphonate
References
Publications (0)
Data not yet available
No reference posted for this study.