Kidney CancerSORHORMNCT01230697
Perspective Evaluation of Hormones Involved in Serum Phosphate Homeostasis in Patients With Metastatic Renal Cells Carcinoma or Hepatocellular Carcinoma Treated With Sorafenib (SORHORM)
An observational study of Kidney Cancer and Liver Cancer, run by University of Turin, Italy at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer, Liver Cancer
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2010to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 advanced renal cells carcinoma and hepatocarcinoma
Who may be able to join
- age over 18 years
- Histologically documented kidney cancer or hepatocarcinoma
- Performance status more than / equal to 2
- Life expectancy > 12 weeks
- in patients with recent surgery, the wound should be completely healed before taking Sorafenib
- 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)
- Appropriate patienty compliance
Who cannot join
- 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,
- previous history of malignant disease with the exception of non melanoma skin cancer curatively treated,
- significant neurologic or psychiatric diseases preventing patients to give a valid informed consent
- Sintomatic brain metastases
- 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
- patients with seizures that need medical treatment
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- History of heterologous transplantation
- Patients with previous or active bleeding
- Dialysis patients
- Patients with history of primary hyperparathyroidism
- Dysphagic patients
- Taking more than four weeks of entry into the study of other bio-chemotherapy treatments
- Previous treatment with Sorafenib
- Recent (<6 months)or concomitant treatment with biphosphonate
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Alfredo Berruti
Orbassano (To), Turin, 10043
Elisa Bellini, MD, (+39) 011 9026 ext. 526, elisa.bellini3@tin.it
Alfredo Berruti, PHD
About this study
Official title: 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
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.
Read the detailed description
Several tyrosin kinase inhibitors are able to induce hypophosphatemia but the mechanisms underling this metabolic disorder are unknown.
Sorafenib is probably the drug in which this metabolic disturbance is most frequent. The aim of the study is identify variation of blood serum analites involved in hypophosphatemia in patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib.
- Conditions
- Kidney Cancer, Liver Cancer
- Being tested
- Sorafenib
- Keywords
- Advanced, hepatocarcinoma
- Medical subject headings
- Kidney Neoplasms, Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Sorafenib 800mg/die oral
| Study group | Role | What they receive |
|---|---|---|
| Sofanenib and Hypophosphatemia | Patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with Sorafenib Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration
Assess the effects of sorafenib hormones involved in phosphate homeostasis
Measured: one year
Secondary outcomes (4)
Identify metabolic differences between renal cells cancer and hepatocarcinoma
identify differences in phosphate hormone behavior between renal cells cancer and hepatocarcinoma.
Measured: one year
Identify variations on bone mass during sorafenib treatment
Assess Sorafenib effects on bone density and the relationship with phosphate related hormones
Measured: one year
Identify correlations between phosphate related hormones and side effects during sorafenib treatment as a Measure of safety and tolerability
Identify the relationship between phpsphate hormones variation and Sorafenib side effects (e.g.asthenia, blood hypertension, skin toxicity).
Measured: one year
Identify correlations between phosphate related hormones variations and patients outcome (TTP and overall survival)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2010
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230697
- Sponsor's protocol ID
- 662010
- Acronym
- SORHORM
- Status last verified
- Jul 2010
- First submitted
- 2 Sep 2010
- Last updated
- 29 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01230697
- Acronym / sponsor ID
- SORHORM / 662010
- Conditions
- Kidney Cancer, Liver Cancer
- Keywords
- Advanced, hepatocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2011 (estimated)
- First posted
- 29 Oct 2010 (estimated)
- 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 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.
Detailed description
Several tyrosin kinase inhibitors are able to induce hypophosphatemia but the mechanisms underling this metabolic disorder are unknown.
Sorafenib is probably the drug in which this metabolic disturbance is most frequent. The aim of the study is identify variation of blood serum analites involved in hypophosphatemia in patients with advanced renal cells carcinoma and hepatocarcinoma in treatment with sorafenib.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sofanenib and Hypophosphatemia | – | Drug: SorafenibPatients with advanced renal cells carcinoma and hepatocarcinoma in treatment with Sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced renal cells carcinoma and hepatocarcinoma
Key inclusion criteria (7 listed)
- age over 18 years
- Histologically documented kidney cancer or hepatocarcinoma
- Performance status more than / equal to 2
- Life expectancy > 12 weeks
- in patients with recent surgery, the wound should be completely healed before taking Sorafenib
Key exclusion criteria (14 listed)
- 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,
- previous history of malignant disease with the exception of non melanoma skin cancer curatively treated,
- significant neurologic or psychiatric diseases preventing patients to give a valid informed consent
- Sintomatic brain metastases
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibSorafenib 800mg/die oral | Drug | Sofanenib and Hypophosphatemia |
Primary outcome
Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration
Time frame: one year
Assess the effects of sorafenib hormones involved in phosphate homeostasis
4 secondary outcomes
Identify metabolic differences between renal cells cancer and hepatocarcinoma
Time frame: one year
Identify variations on bone mass during sorafenib treatment
Time frame: one year
Identify correlations between phosphate related hormones and side effects during sorafenib treatment as a Measure of safety and tolerability
Time frame: one year
Identify correlations between phosphate related hormones variations and patients outcome (TTP and overall survival)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2010.
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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. This study is not recruiting at the moment.
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 Kidney Cancer and Liver Cancer, run by University of Turin, Italy 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 29 Oct 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the value variations of hormones involved in phosphate homeostasis during sorafenib administration (time frame: one year). 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 29 Oct 2010.