Working…
ClinicalTrials.gov
ClinicalTrials.gov 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.
 
ClinicalTrials.gov Identifier: NCT02303015
Recruitment Status : Recruiting
First Posted : November 27, 2014
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Gedske Daugaard, Rigshospitalet, Denmark

Tracking Information
First Submitted Date November 25, 2014
First Posted Date November 27, 2014
Last Update Posted Date March 11, 2020
Study Start Date August 2014
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 26, 2014)
Renal toxicity (Identify genetic variations predicting renal toxicity) [ Time Frame: 1 year ]
Identify genetic variations predicting renal toxicity.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors
Official Title Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples and /or saliva.
Sampling Method Non-Probability Sample
Study Population Danish patients with germ cell cancer diagnosed 1984-2007.
Condition Germ Cell Cancer
Intervention Not Provided
Study Groups/Cohorts Danish germ cell cancer patients
Danish patients with germ cell cancer diagnosed from 1984 to 2007.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 26, 2014)
4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2025
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jakob Lauritsen, M.D. 35459682 jakob.lauritsen@regionh.dk
Contact: Gedske Daugaard, M.D., DMSc 35451125 gedske.daugaard@regionh.dk
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02303015
Other Study ID Numbers DaTeCa01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Gedske Daugaard, Rigshospitalet, Denmark
Study Sponsor Rigshospitalet, Denmark
Collaborators Not Provided
Investigators
Principal Investigator: Gedske Daugaard, MD DMSc Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date March 2020