Comparison of the Methylation Pattern of DNA in Buccal Sw... | NCT02297009

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

NCT02297009

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Terminated

Last Update Posted

Jul 16, 2024Actual

Enrollment

20Actual

Phase

Not provided

Conditions

DNA Methylation

Interventions

Buccal swab

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inactive

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Jul 2024Actual

Completion Date

Jul 2024Actual

First Submitted Date

Oct 31, 2014

First Submission Date that Met QC Criteria

Nov 18, 2014

First Posted Date

Nov 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2024

Last Update Posted Date

Jul 16, 2024Actual

Name	Class
KU Leuven	OTHER

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Volunteers		30 volunteers, half men and half women Buccal swab	Procedure: Buccal swab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Buccal swab	Procedure	Buccal swabs will be taken from the volunteers	Volunteers

Measure	Description	Time Frame
%Methylation (%)		5 weeks

Measure	Description	Time Frame
%Hydroxymethylation (%)		5 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Caucasian

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Students and research staff

Sampling Method

Non-Probability Sample