DNA MethylationNCT02297009
Comparison of the Methylation Pattern of DNA in Buccal Swabs From Different Time Points
An observational study of DNA Methylation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
A buccal swab will be taken using a cotton stick by rubbing it against the buccal mucosa. Samples will be taken from the same participant at different timepoints. DNA will be extracted from the buccal cells on the swabs using a commercial extraction kit and will be quantified by a nano-drop spectrophotometer. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- DNA Methylation
- What is being tested?
- Buccal swab
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2014to Jul 2024
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Students and research staff
Who may be able to join
- Caucasian
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
A buccal swab will be taken using a cotton stick by rubbing it against the buccal mucosa. Samples will be taken from the same participant at different timepoints.
DNA will be extracted from the buccal cells on the swabs using a commercial extraction kit and will be quantified by a nano-drop spectrophotometer.
We will determine global and gene-specific methylation and hydroxymethylation alterations by UPLC/MS/MS. Hydrolyzed DNA into individual nucleosides will be analyzed for the quantitative measurement of 5-methylCytosine and 5-hydroxymethylCytosine on Triple Quadrupole UPLC/MS/MS platform. Secondly, specific methylation in the CpG islands of tumor suppressor and promoter genes, and genes involved in the oxidative stress pathways will be assessed by PCR-pyrosequencing.
- Conditions
- DNA Methylation
- Being tested
- Buccal swab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal swabProcedure or surgery
Buccal swabs will be taken from the volunteers
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | 30 volunteers, half men and half women Buccal swab Receives: Procedure: Buccal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
%Methylation (%)
Measured: 5 weeks
Secondary outcomes (1)
%Hydroxymethylation (%)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2024
- Study completionJul 2024
Why it stopped: Inactive
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DNA MethylationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297009
- Sponsor's protocol ID
- S57170
- Status last verified
- Jul 2024
- First submitted
- 31 Oct 2014
- Last updated
- 16 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Methylation Pattern of DNA in Buccal Swabs From Different Time Points
- ClinicalTrials.gov ID
- NCT02297009
- Acronym / sponsor ID
- S57170
- Conditions
- DNA Methylation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inactive
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Dec 2014
- Primary completion
- Jul 2024 (actual)
- Study completion
- Jul 2024 (actual)
- First posted
- 21 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.
A buccal swab will be taken using a cotton stick by rubbing it against the buccal mucosa. Samples will be taken from the same participant at different timepoints.
DNA will be extracted from the buccal cells on the swabs using a commercial extraction kit and will be quantified by a nano-drop spectrophotometer.
We will determine global and gene-specific methylation and hydroxymethylation alterations by UPLC/MS/MS. Hydrolyzed DNA into individual nucleosides will be analyzed for the quantitative measurement of 5-methylCytosine and 5-hydroxymethylCytosine on Triple Quadrupole UPLC/MS/MS platform. Secondly, specific methylation in the CpG islands of tumor suppressor and promoter genes, and genes involved in the oxidative stress pathways will be assessed by PCR-pyrosequencing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | Procedure: Buccal swab30 volunteers, half men and half women Buccal swab |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Students and research staff
Key inclusion criteria (1 listed)
- Caucasian
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Buccal swabBuccal swabs will be taken from the volunteers | Procedure or surgery | Volunteers |
Primary outcome
%Methylation (%)
Time frame: 5 weeks
1 secondary outcome
%Hydroxymethylation (%)
Time frame: 5 weeks
Results and safety
The study was stopped early (reason given: Inactive). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 DNA Methylation, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 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: stopped early, as of the sponsor's last update on 16 Jul 2024. 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 Belgium. 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 was stopped early (reason given: Inactive). Results are not available in the source record.
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?
%Methylation (%) (time frame: 5 weeks). 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 16 Jul 2024.