Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 22 for:    stem cell kidney | ( Map: Canada )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01014065
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : February 25, 2016
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Tracking Information
First Submitted Date November 12, 2009
First Posted Date November 16, 2009
Last Update Posted Date February 25, 2016
Study Start Date July 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01014065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Prospective Study of Acute Cardiovascular Effects of First-line Sunitinib in Metastatic Renal Cell Carcinoma Patients (SUnitinib Prospective CardiovasculaR Effect)
Official Title A Prospective Study of Acute Cardiovascular Effects of First-line Sunitinib in Metastatic Renal Cell Carcinoma Patients
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and urine banked
Sampling Method Probability Sample
Study Population Patients with renal cell carcinoma scheduled to receive sunitinub.
Condition
  • Renal Cell Carcinoma
  • Cardiotoxicity
  • Heart Failure
  • Hypertension
Intervention Not Provided
Study Groups/Cohorts 1
Patients with renal cell carcinoma scheduled to receive sunitinib
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 Completed
Actual Enrollment
 (submitted: October 15, 2010)
42
Original Estimated Enrollment
 (submitted: November 13, 2009)
20
Actual Study Completion Date January 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01014065
Other Study ID Numbers 00028 / 24942
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AHS Cancer Control Alberta
Study Sponsor AHS Cancer Control Alberta
Collaborators Cross Cancer Institute
Investigators
Principal Investigator: Mark Haykowsky, PhD University of Alberta
PRS Account AHS Cancer Control Alberta
Verification Date March 2012