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TERMINATEDNCT02747173

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

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 specifici...

Lead sponsor: Spanish Oncology Genito-Urinary Group•12 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Spanish Oncology Genito-Urinary Group

Collaborators

Pfizer

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 26, 2018Terms

Trial snapshot

StatusTERMINATED

Phase—

Enrollment4

Start dateOct 2015

Last updatedApr 26, 2018

Condition

Renal Cell Carcinoma

Locations shown

Hospital de Donostia

San Sebastián, Guipuzcoa

Complejo Hospitalario Univ de Santiago de Compostela

Santiago de Compostela, La Coruña

Hospital de Navarra

Pamplona, Navarre

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 26, 2018Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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