NCT02902406

Brief Summary

This is a follow up study which aims to evaluate the correlation between several methylated genes (potential biomarkers) and oral cancers. A prospective case control trial is designed with sample size of at least 300 cases with estimated 200 subjects with precancerous lesion or oral cancer, and 100 subjects with normal oral mucosa. This study is approved by the National Taiwan University Hospital Research Ethics Committee. After signing the informed consent, all subjects will receive an intraoral examination and followed by epithelial cells collection with oral swab. The gDNA will be extracted from the oral swab collected cells and followed by bisulfite conversion procedures. Subsequently, bisulfite converted DNA will be subjected to methylated gene detection by Real-Time PCR. The methylation index (clinical sensitivity and specificity) of oral cancer related genes will be evaluated. For diagnosis confirmation, photos and biopsy specimens will be taken upon observation of abnormal lesion.

Trial Health

55
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Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
Last Updated

May 15, 2018

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

September 12, 2016

Last Update Submit

May 13, 2018

Conditions

Oral Cancer

Outcome Measures

Primary Outcomes (1)

  • DNA methylation

    2 years

Study Arms (2)

normal oral mucosa

oral precancerous lesion or oral cancer

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients come to the Department of Dentistry of National Taiwan University Hospital for oral health care or treatment.

You may qualify if:

  • Subject with age over 20.
  • Subjects with oral mucosal findings (normal, oral mucosal lichen planus, precancerous lesion, and oral cancer) or subjects who have involved in the previous study (NCT01945697).
  • Subjects agrees to sign the informed consent form.

You may not qualify if:

  • Pregnant woman.
  • Subject disagrees to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dentistry National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Central Study Contacts

Shih-Jung Cheng, PhD

CONTACT

886-2-23123456sjcheng56@ntu.edu.tw

Hsiao-Shan Lin, MD

CONTACT

susan@istat.com.tw

Study Design

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

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

April 18, 2016

Primary Completion

April 17, 2019

Last Updated

May 15, 2018

Record last verified: 2016-09

Locations

TW(1)