NCT02303015

Brief Summary

The purpose of this study is to identify genetic variations in survivors of testicular cancer and connect these variations to differences in risks of late effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

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

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

8.6 years

First QC Date

November 25, 2014

Last Update Submit

November 19, 2023

Conditions

Germ Cell Cancer

Keywords

Germ cell cancerLate toxicityRenal impairmentCardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Renal toxicity (Identify genetic variations predicting renal toxicity)

    Identify genetic variations predicting renal toxicity.

    1 year

Study Arms (1)

Danish germ cell cancer patients

Danish patients with germ cell cancer diagnosed from 1984 to 2007.

Eligibility Criteria

Age15 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Danish patients with germ cell cancer diagnosed 1984-2007.

You may qualify if:

  • Danish citizen
  • Diagnosed with germ cell cancer from 1984 to 2007
  • Treated initially at a Danish hospital
  • Treated with standard treatment regimens.

You may not qualify if:

  • Treated initially at a foreign hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Oncology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and /or saliva.

MeSH Terms

Conditions

Neoplasms, Germ Cell and EmbryonalRenal InsufficiencyCardiovascular Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Gedske Daugaard, MD DMSc

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor M.D. DMSc

Study Record Dates

First Submitted

November 25, 2014

First Posted

November 27, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)