NCT02297009

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

9.6 years

First QC Date

October 31, 2014

Last Update Submit

July 12, 2024

Conditions

DNA Methylation

Outcome Measures

Primary Outcomes (1)

  • %Methylation (%)

    5 weeks

Secondary Outcomes (1)

  • %Hydroxymethylation (%)

    5 weeks

Study Arms (1)

Volunteers

30 volunteers, half men and half women Buccal swab

Procedure: Buccal swab

Interventions

Buccal swabPROCEDURE

Buccal swabs will be taken from the volunteers

Volunteers

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Students and research staff

You may qualify if:

  • Caucasian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BIOMAT

Leuven, 3000, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal cells

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 21, 2014

Study Start

December 1, 2014

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

July 16, 2024

Record last verified: 2024-07

Locations

BE(1)