Genetic DiseaseKG01NCT02266615
Biobank Clinical Genetics Maastricht (KG01)
An observational study of Genetic Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Collection of coded biomaterial and clinical data with patients consent for future research. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Genetic Disease
- What is being tested?
- Biobanking of biomaterial for future genetic research.
- How many people
- 3,600 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: New patients visiting the out patient clinic of the department of Clinical Genetics of the Maastricht University Medical Hospital and who get blood or tissue sampled for DNA diagnostics.
Who may be able to join
- New patients visiting the out patient clinic of the department of Clinical Genetics of the Maastricht University Medical Hospital
- Withdrawal of body material for genetic diagnostics.
Who cannot join
- Patient does not understand the Dutch language.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6229 HV
M. Eijck-Vievermans, +313876447, margo.vievermans@mumc.nl
About this study
Official title: Biobank Clinical Genetics Maastricht
Collection of coded biomaterial and clinical data with patients consent for future research.
Read the detailed description
Collection of coded biomaterial and clinical data with patients consent for future research, with the purpose to indentify new gene mutation and prossibilities for treatment in the future.
- Conditions
- Genetic Disease
- Being tested
- Biobanking of biomaterial for future genetic research.
- Medical subject headings
- Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobanking of biomaterial for future genetic research.Genetic
| Study group | Role | What they receive |
|---|---|---|
| Genetic research in 5 areas. | Cardiogenetics; Intellectual Disability, Multiple Congenital Abnormalities and Rare Diseases; Oncogenetics; Dermatogenetics; Reproductive Genetics. Receives: Genetic: Biobanking of biomaterial for future genetic research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing genes to discover unknown functions
The biobanked bio material and medical data can be used for future research to learn more about the function of genes.
Measured: Genes will be sequenced and compared, within an expected average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2024
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Prospective
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- W. van Zelst-Stams, MD, PhD, Study director, Head of department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266615
- Sponsor's protocol ID
- METC-14-4-077
- Acronym
- KG01
- Status last verified
- May 2025
- First submitted
- 18 Sep 2014
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobank Clinical Genetics Maastricht
- ClinicalTrials.gov ID
- NCT02266615
- Acronym / sponsor ID
- KG01 / METC-14-4-077
- Conditions
- Genetic Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2024 (actual)
- Study completion
- Jan 2035 (estimated)
- First posted
- 17 Oct 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.
Collection of coded biomaterial and clinical data with patients consent for future research.
Detailed description
Collection of coded biomaterial and clinical data with patients consent for future research, with the purpose to indentify new gene mutation and prossibilities for treatment in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genetic research in 5 areas. | – | Genetic: Biobanking of biomaterial for future genetic research.Cardiogenetics; Intellectual Disability, Multiple Congenital Abnormalities and Rare Diseases; Oncogenetics; Dermatogenetics; Reproductive Genetics. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- New patients visiting the out patient clinic of the department of Clinical Genetics of the Maastricht University Medical Hospital and who get blood or tissue sampled for DNA diagnostics.
Key inclusion criteria (2 listed)
- New patients visiting the out patient clinic of the department of Clinical Genetics of the Maastricht University Medical Hospital
- Withdrawal of body material for genetic diagnostics.
Key exclusion criteria (1 listed)
- Patient does not understand the Dutch language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biobanking of biomaterial for future genetic research. | Genetic | Genetic research in 5 areas. |
Primary outcome
Comparing genes to discover unknown functions
Time frame: Genes will be sequenced and compared, within an expected average of 6 months.
The biobanked bio material and medical data can be used for future research to learn more about the function of genes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
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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.
W. van Zelst-Stams, MD, PhD study director
Head of department
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 Genetic Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
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 2 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: looking for participants now, as of the sponsor's last update on 6 Oct 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact I. Krapels, MD, PhD (+31433875880, ingrid.krapels@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing genes to discover unknown functions (time frame: Genes will be sequenced and compared, within an expected average of 6 months.). 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 6 Oct 2025.