Working... Menu

Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02303015
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : March 26, 2019
Information provided by (Responsible Party):
Gedske Daugaard, Rigshospitalet, Denmark

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.

Condition or disease
Germ Cell Cancer

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors
Study Start Date : August 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Renal toxicity (Identify genetic variations predicting renal toxicity) [ Time Frame: 1 year ]
    Identify genetic variations predicting renal toxicity.

Biospecimen Retention:   Samples With DNA
Blood samples and /or saliva.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Danish patients with germ cell cancer diagnosed 1984-2007.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02303015

Layout table for location contacts
Contact: Jakob Lauritsen, M.D. 35459682
Contact: Gedske Daugaard, M.D., DMSc 35451125

Layout table for location information
Dept. of Oncology, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Layout table for investigator information
Principal Investigator: Gedske Daugaard, MD DMSc Rigshospitalet, Denmark

Layout table for additonal information
Responsible Party: Gedske Daugaard, Professor M.D. DMSc, Rigshospitalet, Denmark Identifier: NCT02303015     History of Changes
Other Study ID Numbers: DaTeCa01
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gedske Daugaard, Rigshospitalet, Denmark:
Germ cell cancer
Late toxicity
Renal impairment
Cardiovascular disease

Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders