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Epstein-Barr Detection in Oral Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01039272
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
UPECLIN HC FM Botucatu Unesp

Tracking Information
First Submitted Date December 22, 2009
First Posted Date December 24, 2009
Last Update Posted Date June 25, 2015
Study Start Date March 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2015)
presence of EBV [ Time Frame: 1 hour ]
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01039272 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epstein-Barr Detection in Oral Cancer
Official Title Epstein-Barr Detection in Squamous Cell Carcinoma and Healthy Oral Mucosa
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).
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
paraffin-embedded tissue samples
Sampling Method Probability Sample
Study Population oral care clinic, community sample
Condition Oral Cancer
Intervention Not Provided
Study Groups/Cohorts
  • oral cancer
    patients with oral squamous cell carcinoma
  • control group
    healthy patients without any oral pathology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 22, 2009)
60
Original Actual Enrollment Same as current
Actual Study Completion Date June 2015
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • without oral squamous cell carcinoma
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT01039272
Other Study ID Numbers upeclin/FOA-Unesp-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party UPECLIN HC FM Botucatu Unesp
Study Sponsor UPECLIN HC FM Botucatu Unesp
Collaborators Not Provided
Investigators
Principal Investigator: Glauco Issamu I Miyahara, Professor Department of Pathology and Propaedeutics, Sao Paulo State University, Unesp, Araçatuba/SP
Study Chair: Lívia T Arêde, student Department of Pathology and Propaedeutics, Sao Paulo State University, Unesp, Araçatuba/SP
PRS Account UPECLIN HC FM Botucatu Unesp
Verification Date June 2015