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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00705094
Other study ID # GU-24167
Secondary ID
Status Completed
Phase N/A
First received June 23, 2008
Last updated September 29, 2014
Start date September 2008
Est. completion date July 2012

Study information

Verified date September 2014
Source AHS Cancer Control Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 2012
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Canada Cross Cancer Institute Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

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