Assessment of Bone Biomarkers for TKI Response in RCC With Bone Metastases, HRQoL and Comparison of Imaging Techniques
METHEOS
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
1 other identifier
observational
4
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2015
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 26, 2018
April 1, 2018
2.5 years
April 23, 2015
April 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess bone biomarkers in response to TKI
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.
Every 3 months until an average of 12 months
Secondary Outcomes (9)
Progression free survival
An average of 12 months
Objective response rate
An average of 12 months
Measurements in time of bone metastases in RCC using whole body magnetic resonance and bone scintigraphy
Every 3 months until an average of 12 months
Change and correlation of magnetic resonance and CT results in the assessment of global disease response to TKI. Using RECIST and MASS criteria
Every 3 months until an average of 12 months
Quality of life of patients with RCC and bone metastases throughout the study period using the FSI-15
Every 3 months until an average of 12 months
- +4 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
patients with a diagnosis of a stage IV renal cell carcinoma with confirmed presence of bone metastases, subsidiary of treatment with an TKI in first line
You may qualify if:
- Diagnosis of a stage IV renal cell carcinoma with confirmed presence of bone metastases, subsidiary of treatment with an TKI in first line
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spanish Oncology Genito-Urinary Grouplead
- Pfizercollaborator
Study Sites (12)
Hospital de Donostia
San Sebastián, Guipuzcoa, 20080, Spain
Complejo Hospitalario Univ de Santiago de Compostela
Santiago de Compostela, La Coruña, 15706, Spain
Hospital de Navarra
Pamplona, Navarre, 31008, Spain
Complejo Hospitalario Univ de Vigo
Vigo, Pontevedra, 36204, Spain
Hospital Universitario central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Consorcio Hospitalario Parc Tauli
Barcelona, 08208, Spain
Complejo Hospitalario de León
León, 24071, Spain
Hospital Univ Lucus Augusti
Lugo, 27003, Spain
Complejo Hospitalario de Ourense
Ourense, 32005, Spain
Instituto Valenciano de Oncologia
Valencia, 46009, Spain
Hospital Universitario La Fe
Valencia, 46026, Spain
Hospital Miguel Servet
Zaragoza, 50009, Spain
Biospecimen
Blood plasma samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sergio Vazquez, MD
Hospital Univ Lucus Augusti
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2015
First Posted
April 21, 2016
Study Start
October 1, 2015
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
April 26, 2018
Record last verified: 2018-04