Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors

November 19, 2023 updated by: Gedske Daugaard, Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Detailed Description

Identification of late-effects through questionnaires and linkage to national registries. DNA samples will be gathered through buccal swabs or saliva kits and analysed with whole exome-sequencing.

Study Type

Observational

Enrollment (Actual)

430

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Dept. of Oncology, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Danish patients with germ cell cancer diagnosed 1984-2007.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Treated initially at a foreign hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal toxicity (Identify genetic variations predicting renal toxicity)
Time Frame: 1 year
Identify genetic variations predicting renal toxicity.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Gedske Daugaard, MD DMSc, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimated)

November 27, 2014

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DaTeCa01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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