Germ Cell CancerNCT02303015
Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors
An observational study of Germ Cell Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older, men only
- Conditions the study is for
- Germ Cell Cancer
- How many people
- 430 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Danish patients with germ cell cancer diagnosed 1984-2007.
Who may be able to join
- Danish citizen
- Diagnosed with germ cell cancer from 1984 to 2007
- Treated initially at a Danish hospital
- Treated with standard treatment regimens.
Who cannot join
- Treated initially at a foreign hospital
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Germ Cell Cancer
- Keywords
- Germ cell cancer, Late toxicity, Renal impairment, Cardiovascular disease
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal, Renal Insufficiency, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Danish germ cell cancer patients | Danish patients with germ cell cancer diagnosed from 1984 to 2007. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal toxicity (Identify genetic variations predicting renal toxicity)
Identify genetic variations predicting renal toxicity.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2023
- Study completionJun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gedske Daugaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gedske Daugaard, MD DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303015
- Sponsor's protocol ID
- DaTeCa01
- Status last verified
- Nov 2023
- First submitted
- 25 Nov 2014
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toxicity Attributed to Genetic Polymorphisms in Testicular Germ Cell Tumor Survivors
- ClinicalTrials.gov ID
- NCT02303015
- Acronym / sponsor ID
- DaTeCa01
- Conditions
- Germ Cell Cancer
- Keywords
- Germ cell cancer, Late toxicity, Renal impairment, Cardiovascular disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2023 (actual)
- Study completion
- Jun 2023 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Danish germ cell cancer patients | – | –Danish patients with germ cell cancer diagnosed from 1984 to 2007. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Danish patients with germ cell cancer diagnosed 1984-2007.
Key inclusion criteria (4 listed)
- Danish citizen
- Diagnosed with germ cell cancer from 1984 to 2007
- Treated initially at a Danish hospital
- Treated with standard treatment regimens.
Key exclusion criteria (1 listed)
- Treated initially at a foreign hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Renal toxicity (Identify genetic variations predicting renal toxicity)
Time frame: 1 year
Identify genetic variations predicting renal toxicity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gedske Daugaard, MD DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Germ Cell Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal toxicity (Identify genetic variations predicting renal toxicity) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.