NCT00705094

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

2.7 years

First QC Date

June 23, 2008

Last Update Submit

September 29, 2014

Conditions

Keywords

cardiovascular risk factorscardiac functionVO2peakChemotherapy

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Testicular NeoplasmsSeminoma

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersGerminomaNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic Type

Study Officials

  • Mark Haykowsky, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 25, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2011

Study Completion

July 1, 2012

Last Updated

October 1, 2014

Record last verified: 2014-09

Locations