Comparison of the Methylation Pattern of DNA in Buccal Swabs From Different Time Points

DNA Methylation Clinical Trial

Official title:

Comparison of the Methylation Pattern of DNA in Buccal Swabs From Different Time Points

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02297009
• Other study ID #: S57170
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2014
• Last updated: January 13, 2015
• Start date: December 2014
• Est. completion date: September 2018

Study information

• Verified date: October 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Kirsten Van Landuyt, Prof. Dr
• Email: kirsten.vanlanduyt[@]med.kuleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2018
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Caucasian

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• DNA Methylation

Intervention

Procedure:
• Buccal swab
Buccal swabs will be taken from the volunteers

Locations

Country	Name	City	State
Belgium	BIOMAT	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%Methylation (%)		5 weeks	No
Secondary	%Hydroxymethylation (%)		5 weeks	No