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

NCT02747173

Last updated date
Study Location
Hospital Universitario central de Asturias
Oviedo, Asturias, 33011, Spain
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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:

  • 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.
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
 (submitted: April 25, 2018)
4
Original Estimated Enrollment
 (submitted: April 18, 2016)
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:

  • 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
Sex/Gender
Sexes Eligible for Study:All
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
Principal Investigator:Sergio Vazquez, MDHospital Univ Lucus Augusti
PRS Account Spanish Oncology Genito-Urinary Group
Verification Date April 2018