NCT01039272

Brief Summary

The aim of this study is to analyze oral squamous cell carcinoma and healthy oral mucosa for the possible presence of Epstein-Barr virus (EBV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

Enrollment Period

1 month

First QC Date

December 22, 2009

Last Update Submit

June 24, 2015

Conditions

Oral Cancer

Keywords

oral cancerEBVPCR

Outcome Measures

Primary Outcomes (1)

  • presence of EBV

    Epstein-Barr virus has been implicated in a range of malignant neoplasms, including in some studies, in the aetiology of oral squamous cell carcinoma but the influence of EBV in oral cancer remains unclear. This study will examine the prevalence of EBV infection in oral cancer by means of nested polymerase chain reaction.

    1 hour

Study Arms (2)

oral cancer

patients with oral squamous cell carcinoma

control group

healthy patients without any oral pathology

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

oral care clinic, community sample

You may qualify if:

  • patients of Oral Cancer Centre - UNESP/Araçatuba - SP
  • with oral squamous cell carcinoma

You may not qualify if:

  • without oral squamous cell carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pathology and Propaedeutics, Sao Paulo State University, Unesp, Araçatuba/SP

Araçatuba, São Paulo, 16025-050, Brazil

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

paraffin-embedded tissue samples

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Glauco Issamu I Miyahara, Professor

    Department of Pathology and Propaedeutics, Sao Paulo State University, Unesp, Araçatuba/SP

    PRINCIPAL INVESTIGATOR

  • Lívia T Arêde, student

    Department of Pathology and Propaedeutics, Sao Paulo State University, Unesp, Araçatuba/SP

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

March 1, 2008

Primary Completion

April 1, 2008

Study Completion

June 1, 2015

Last Updated

June 25, 2015

Record last verified: 2015-06

Locations

BR(1)