Renal Cell CarcinomaMETHEOSNCT02747173
Assessment of Bone Biomarkers for TKI Response in RCC With Bone Metastases, HRQoL and Comparison of Imaging Techniques
An observational study of Renal Cell Carcinoma, run by Spanish Oncology Genito-Urinary Group at 12 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 4 participants
- Where
- 12 sitesSpain
- Study dates
- Oct 2015to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Consorcio Hospitalario Parc Tauli
Barcelona, 08208
Complejo Hospitalario de León
León, 24071
Hospital Univ Lucus Augusti
Lugo, 27003
Complejo Hospitalario de Ourense
Ourense, 32005
Hospital Universitario central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital de Navarra
Pamplona, Navarre, 31008
Hospital de Donostia
San Sebastián, Guipuzcoa, 20080
Complejo Hospitalario Univ de Santiago de Compostela
Santiago de Compostela, La Coruña, 15706
Instituto Valenciano de Oncologia
Valencia, 46009
Hospital Universitario La Fe
Valencia, 46026
Complejo Hospitalario Univ de Vigo
Vigo, Pontevedra, 36204
Hospital Miguel Servet
Zaragoza, 50009
About this study
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
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.
Read the 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.
- Conditions
- Renal Cell Carcinoma
- Keywords
- metastatic, bone metastases
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 3 months until an average of 12 months
Secondary outcomes (9)
Progression free survival
Assess the efficacy of TKI in patients with RCC with bone metastases.
Measured: An average of 12 months
Objective response rate
Assess the efficacy of TKI in patients with RCC with bone metastases.
Measured: An average of 12 months
Measurements in time of bone metastases in RCC using whole body magnetic resonance and bone scintigraphy
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
Measured: 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
Compare globally the magnetic resonance and CT results in the assessment of disease response to TKI using RECIST and MASS criteria
Measured: 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
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)
Measured: 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
Assess the quality of life of patients with RCC and bone metastases using the FACT-BP questionnaire
Measured: 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
Assess the efficacy of TKI in the improvement of pain produced by bone metastases assessing the use of analgesics.
Measured: 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
Assess the efficacy of TKI in the improvement of pain produced by bone metastases using the Numeric Pain Rating Scale
Measured: every week until an average of 12 months
Assessment osteonecrosis of the jaw with use of biphosphonates or denosumab throughout the study period
Risk of osteonecrosis of the jaw with use of biphosphonates or denosumab
Measured: every week until an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Oncology Genito-Urinary Group
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Sergio Vazquez, MD, Principal investigator, Hospital Univ Lucus Augusti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747173
- Sponsor's protocol ID
- SOG-ANG-2014-01
- Acronym
- METHEOS
- Status last verified
- Apr 2018
- First submitted
- 23 Apr 2015
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02747173
- Acronym / sponsor ID
- METHEOS / SOG-ANG-2014-01
- Conditions
- Renal Cell Carcinoma
- Keywords
- metastatic, bone metastases
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Spanish Oncology Genito-Urinary GroupUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
Progression free survival
Time frame: An average of 12 months
Objective response rate
Time frame: 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
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
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
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
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
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
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Vazquez, MD principal investigator
Hospital Univ Lucus Augusti
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Spanish Oncology Genito-Urinary Group at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess bone biomarkers in response to TKI (time frame: Every 3 months until an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018; AzTrials last refreshed its copy on 26 Oct 2026.