NCT00483418

Brief Summary

The purpose of this study is to survey the total serum testosterone levels in male patients with hormone-independent malignancies. The prevalence of hypogonadism is not known, but is thought to be significant. Results will be adjusted for age and stratified for type of cancer, stage, study site,and presence of opiate use for pain management, which is known to reduce testosterone levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
425

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Typical duration 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

Study Start

First participant enrolled

June 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 7, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 11, 2011

Status Verified

March 1, 2011

Enrollment Period

2.5 years

First QC Date

June 6, 2007

Last Update Submit

March 10, 2011

Conditions

Hypogonadism

Keywords

malecancer

Eligibility Criteria

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

Men with non-hormone dependent cancers who are having blood drawn for other purposes before 12 noon.

You may qualify if:

  • Age 18 or older
  • Male Cancer patients coming to oncology appointments for treatment or follow-up
  • Must be able to answer questionnaire in english, alone or with assistance
  • Informed consent

You may not qualify if:

  • Known HIV infection
  • Known hypogonadism
  • testosterone or DHEA supplementation within 3 months
  • prostate, breast, or testicular cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

HypogonadismNeoplasms

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • Stewart B Fleishman, MD

    Continuum Cancer Centers of New York

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2007

First Posted

June 7, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 11, 2011

Record last verified: 2011-03

Locations

US(1)