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Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00705094
First Posted: June 25, 2008
Last Update Posted: October 1, 2014
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.
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  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

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

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Estimated Enrollment: 30
Study Start Date: September 2008
Study Completion Date: July 2012
Primary Completion Date: May 2011 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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): NCT00705094


Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Mark Haykowsky, PhD University of Alberta
  More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00705094     History of Changes
Other Study ID Numbers: GU-24167
First Submitted: June 23, 2008
First Posted: June 25, 2008
Last Update Posted: October 1, 2014
Last Verified: September 2014

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

Additional relevant MeSH terms:
Seminoma
Testicular Neoplasms
Germinoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders