Assessment of Bone Biomarkers for TKI Response in RCC With Bone Metastases, HRQoL and Comparison of Imaging Techniques
NCT02747173
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- 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
- 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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Descriptive Information | ||||
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Brief Title | Assessment of Bone Biomarkers for TKI Response in RCC With Bone Metastases, HRQoL and Comparison of Imaging Techniques | |||
Official Title | 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 | |||
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. | |||
Detailed Description | Prospective observational study to assess:
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: Blood plasma samples | |||
Sampling Method | Non-Probability Sample | |||
Study Population | 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 | |||
Condition | Renal Cell Carcinoma | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | 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. | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Terminated | |||
Actual Enrollment | 4 | |||
Original Estimated Enrollment | 60 | |||
Actual Study Completion Date | April 2018 | |||
Actual Primary Completion Date | April 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
| |||
Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT02747173 | |||
Other Study ID Numbers | SOG-ANG-2014-01 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Spanish Oncology Genito-Urinary Group | |||
Study Sponsor | Spanish Oncology Genito-Urinary Group | |||
Collaborators | Pfizer | |||
Investigators |
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PRS Account | Spanish Oncology Genito-Urinary Group | |||
Verification Date | April 2018 |