NCT02240966

Brief Summary

The purpose of this study is to investigate the prevalence of signs and symptoms of hypogonadism in three groups of testicular cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

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

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

September 8, 2014

Last Update Submit

July 13, 2016

Conditions

Metabolic SyndromeHypogonadismCardio-vascular Disease

Keywords

Testicular NeoplasmsHypogonadismMetabolic SyndromeTreatment related late effects

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Metabolic Syndrome in the three groups of testicular cancer survivors according to International Diabetes Federation Guidelines and US National Cholesterol Education Program Adult Treatment Panel III criteria

    Up to 12 months

Secondary Outcomes (11)

  • Lean body mass (Kilogram)

    Up to 12 months

  • Bone Mineral Density (Gram/cm2)

    Up to 12 months

  • Pulmonary Function: Total lung capacity, Forced vital capacity, FEV1, Diffusing capacity or of the lung for carbon monoxide

    Up to 12 months

  • Renal function (Glomerular Filtration Rate ml/min)

    Up to 12 months

  • Fasting Blood Glucose

    Up to 12 months

  • +6 more secondary outcomes

Eligibility Criteria

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

Testicular cancer survivors

You may qualify if:

  • Earlier treatment of testicular germ cell cancer
  • No sign of relapse \> 1 year since latest treatment
  • Testosterone \< 12 nmol/L and luteinizing hormone \> 8 IE/L OR
  • Testosterone \> 12 nmol/L and LH \> 8 IE/L OR
  • Testosterone and LH within their normal ranges

You may not qualify if:

  • Testosterone substitution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • Bandak M, Jorgensen N, Juul A, Lauritsen J, Oturai PS, Mortensen J, Hojman P, Helge JW, Daugaard G. Leydig cell dysfunction, systemic inflammation and metabolic syndrome in long-term testicular cancer survivors. Eur J Cancer. 2017 Oct;84:9-17. doi: 10.1016/j.ejca.2017.07.006. Epub 2017 Jul 31.

    PMID: 28772110DERIVED

  • Bandak M, Jorgensen N, Juul A, Lauritsen J, Kier MGG, Mortensen MS, Oturai PS, Mortensen J, Hojman P, Helge JW, Daugaard G. Reproductive hormones and metabolic syndrome in 24 testicular cancer survivors and their biological brothers. Andrology. 2017 Jul;5(4):718-724. doi: 10.1111/andr.12355. Epub 2017 Jun 9.

    PMID: 28598554DERIVED

MeSH Terms

Conditions

Metabolic SyndromeHypogonadismTesticular Neoplasms

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGonadal DisordersEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesTesticular Diseases

Study Officials

  • Gedske Daugaard, DMSc

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 8, 2014

First Posted

September 16, 2014

Study Start

August 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-07

Locations

DK(1)