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Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients

This study is not yet open for participant recruitment.
Verified by Alberta Cancer Board, June 2008

Sponsored by: Alberta Cancer Board
Information provided by: Alberta Cancer Board
ClinicalTrials.gov Identifier: NCT00705094
  Purpose

For many years, researchers and doctors have studied different kinds of treatments to improve the survival of men with testicular cancer. However, recent research has shown that many years later, men who had testicular cancer appear to be at higher risk for developing heart disease (heart attack or heart failure), especially if they received chemotherapy. Since these studies were done many years after men received treatment, there was no way to know if other factors contributed to the health problems they experienced. This study is being done because it would be helpful to study heart function and cardiovascular disease risk factors of men who have been diagnosed with testicular cancer, before and after they receive chemotherapy treatment compared to men who receive treatment with surgery alone.


Condition
Testicular Cancer
Seminoma
Non-Seminomatous

MedlinePlus related topics:   Cancer    Testicular Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients

Further study details as provided by Alberta Cancer Board:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   30
Study Start Date:   September 2008
Estimated Primary Completion Date:   September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1
Testicular cancer patients who have received surgery and are scheduled for surveillance
2
Testicular cancer patients who have received surgery and are scheduled for chemotherapy

Detailed Description:

The aim of this pilot study is to examine global and regional LV systolic and diastolic function, cardiac output, cardiac reserve, VO2peak and CVD risk profile in males recently diagnosed with testicular cancer treated with surgery alone or surgery and chemotherapy.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample

Study Population

testicular cancer patients who have recieved surgery and are scheduled for either chemotherapy or surveillance


Criteria

Inclusion Criteria:

  • surgery and surveillance
  • surgery and multi-cycle chemotherapy
  • both good and intermediate prognosis seminoma and non-seminomatous germ cell testicular tumors
  • Karnofsky performance index > 70%
  • no contraindications to cardiopulmonary testing

Exclusion Criteria:

  • documented cardiovascular disease or evidence of myocardial ischemia on the incremental exercise (VO2peak) test.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705094

Contacts
Contact: Edith Pituskin, RN, PhD Student     (780) 432 - 8792     pituskin@ualberta.ca    

Locations
Canada, Alberta
Cross Cancer Institute     Not yet recruiting
      Edmonton, Alberta, Canada, T6G 1Z2
      Contact: Clinical Research Unit     780-989-8152     clinical_trials_cci@cancerboard.ab.ca    
      Principal Investigator: Mark Haykowsky, PhD            

Sponsors and Collaborators
Alberta Cancer Board

Investigators
Principal Investigator:     Mark Haykowsky, PhD     University of Alberta    
  More Information


Responsible Party:   University of Alberta ( Mark Haykowsky, PhD )
Study ID Numbers:   GU-24167
First Received:   June 23, 2008
Last Updated:   September 22, 2008
ClinicalTrials.gov Identifier:   NCT00705094
Health Authority:   Canada: Canadian Institutes of Health Research

Keywords provided by Alberta Cancer Board:
cardiovascular risk factors  
cardiac function  
VO2peak  
Chemotherapy  

Study placed in the following topic categories:
Genital Neoplasms, Male
Gonadal Disorders
Neoplasms, Germ Cell and Embryonal
Testicular Diseases
Endocrine System Diseases
Seminoma
Testicular cancer
Urogenital Neoplasms
Endocrinopathy
Testicular Neoplasms
Genital Diseases, Male
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Germinoma

ClinicalTrials.gov processed this record on September 23, 2008




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