Assessment of Bone Biomarkers for TKI Response in RCC With Bone Metastases, HRQoL and Comparison of Imaging Techniques

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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Prospective observational study to assess:

* Bone predictive biomarkers for tyrosine kinase inhibitor (TKI) response in renal cell carcinoma (RCC) patients with bone metastasis - Health Related Quality of Life (HRQoL) with TKI
* Comparison of the sensitivity and specificity of whole body magnetic resonance versus bone scintigraphy and versus Computerized tomography (CT) in the assessment of metastatic lesions at bone level and at other sites.

Conditions

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Renal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RCC patients with bone metastases

Patients will receive the standard TKI treatment for first line treatment naive metastatic RCC. Sunitinib or pazopanib as decided by the investigator.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No