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Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors

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ClinicalTrials.gov Identifier: NCT02303015
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : March 26, 2019
Sponsor:
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.

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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


Group/Cohort
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

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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02303015


Contacts
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Contact: Jakob Lauritsen, M.D. 35459682 jakob.lauritsen@regionh.dk
Contact: Gedske Daugaard, M.D., DMSc 35451125 gedske.daugaard@regionh.dk

Locations
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Denmark
Dept. of Oncology, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Gedske Daugaard, MD DMSc Rigshospitalet, Denmark

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Responsible Party: Gedske Daugaard, Professor M.D. DMSc, Rigshospitalet, Denmark
ClinicalTrials.gov 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:
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Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders