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

April 25, 2018 updated by: Spanish Oncology Genito-Urinary Group

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08208
        • Consorcio Hospitalario Parc Tauli
      • Leon, Spain, 24071
        • Complejo Hospitalario de León
      • Lugo, Spain, 27003
        • Hospital Univ Lucus Augusti
      • Ourense, Spain, 32005
        • Complejo Hospitalario de Ourense
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Guipuzcoa
      • San Sebastián, Guipuzcoa, Spain, 20080
        • Hospital de Donostia
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15706
        • Complejo Hospitalario Univ de Santiago de Compostela
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Hospital de Navarra
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36204
        • Complejo Hospitalario Univ de Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess bone biomarkers in response to TKI
Time Frame: Every 3 months until an average of 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: An average of 12 months
Assess the efficacy of TKI in patients with RCC with bone metastases.
An average of 12 months
Objective response rate
Time Frame: An average of 12 months
Assess the efficacy of TKI in patients with RCC with bone metastases.
An average of 12 months
Measurements in time of bone metastases in RCC using whole body magnetic resonance and bone scintigraphy
Time Frame: Every 3 months until an average of 12 months
Comparison of the sensibility and specificity of whole body magnetic resonance and bone scintigraphy in the detection of metastases and response assessment of bone metastases in RCC
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
Time Frame: Every 3 months until an average of 12 months
Compare globally the magnetic resonance and CT results in the assessment of 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
Time Frame: Every 3 months until an average of 12 months
Assess the quality of life of patients with RCC and bone metastases using the 15 item Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-15)
Every 3 months until an average of 12 months
Quality of life of patients with RCC and bone metastases throughout the study period using FACT-BP
Time Frame: Every 3 months until an average of 12 months
Assess the quality of life of patients with RCC and bone metastases using the FACT-BP questionnaire
Every 3 months until an average of 12 months
Efficacy of TKI in the improvement of pain produced by bone metastases throughout the study period
Time Frame: every week until an average of 12 months
Assess the efficacy of TKI in the improvement of pain produced by bone metastases assessing the use of analgesics.
every week until an average of 12 months
Efficacy of TKI in the improvement of pain produced by bone metastases throughout the study period using the NPR scale
Time Frame: every week until an average of 12 months
Assess the efficacy of TKI in the improvement of pain produced by bone metastases using the Numeric Pain Rating Scale
every week until an average of 12 months
Assessment osteonecrosis of the jaw with use of biphosphonates or denosumab throughout the study period
Time Frame: every week until an average of 12 months
Risk of osteonecrosis of the jaw with use of biphosphonates or denosumab
every week until an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spanish Oncology Genito-Urinary Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sergio Vazquez, MD, Hospital Univ Lucus Augusti

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SOG-ANG-2014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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