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A Prospective Study of Acute Cardiovascular Effects of First-line Sunitinib in Metastatic Renal Cell Carcinoma Patients (SUnitinib Prospective CardiovasculaR Effect) (SUPER)

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ClinicalTrials.gov Identifier: NCT01014065
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : February 25, 2016
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
While sunitinib can be very helpful to treat kidney cancer, these medications can also cause side effects, including heart damage. Studies performed in the past did not look at heart function in detail, so the investigators do not know what happens to the heart when people start sunitinib treatment. The aim of the study is to prospectively study acute effects of sunitinib on heart function, overall fitness and blood markers of heart disease.

Condition or disease
Renal Cell Carcinoma Cardiotoxicity Heart Failure Hypertension

Detailed Description:
Participants will undergo cardiac MRI, maximal exercise testing(VO2 peak), blood and urine samples before and after 2 treatments of sunitinib. An extra blood sample will be collected the 2nd week of the first treatment to check blood levels of sunitinib. We will also examine routine CT scans to study body composition.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Acute Cardiovascular Effects of First-line Sunitinib in Metastatic Renal Cell Carcinoma Patients
Study Start Date : July 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 2013

Patients with renal cell carcinoma scheduled to receive sunitinib

Biospecimen Retention:   Samples With DNA
Blood and urine banked

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with renal cell carcinoma scheduled to receive sunitinub.

Inclusion Criteria:

  • Histologic diagnosis of metastatic renal cell carcinoma
  • Eligible to receive first-line sunitinib
  • Willingness to attend Cross Cancer Institute and University of Alberta for study-related assessments
  • Karnofsky Performance Status (KPS)82 ≥ 70
  • Age ≥ 18 years of age
  • Adequate creatinine clearance to receive gadolinium
  • All patients with bone metastases are eligible; those with lesions identified at weight-bearing bones will undergo plain films to evaluate fracture risk prior to CPET;
  • Fluent in English language
  • No contraindication to MRI or other concern eg., metallic implants, claustrophobia

Exclusion Criteria:

  • Prior systemic therapy for mRCC
  • Documented history of major cardiac event in last year i.e. MI, unstable angina, CABG, symptomatic CHF, CVA or TIA, or pulmonary embolism
  • Pregnancy
  • Other severe condition or abnormality that, in the judgement of the investigator or treating oncologist, would make participation in this study inappropriate
  • Unstable brain metastases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014065

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Canada, Alberta
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, Canada
Sponsors and Collaborators
AHS Cancer Control Alberta
Cross Cancer Institute
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Principal Investigator: Mark Haykowsky, PhD University of Alberta
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT01014065    
Other Study ID Numbers: 00028 / 24942
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: March 2012
Keywords provided by AHS Cancer Control Alberta:
cardiac MRI
maximal exercise testing
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cardiovascular Diseases
Heart Diseases
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries