Oral CancerNCT01039272

Epstein-Barr Detection in Oral Cancer

An observational study of Oral Cancer, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Oral Cancer
Type of treatment: Pill or oral medicine
How many people: 60 participants
Where: 1 siteBrazil
Study dates: Mar 2008to Jun 2015
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: oral care clinic, community sample

Who may be able to join

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

Who cannot join

without oral squamous cell carcinoma

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Department of Pathology and Propaedeutics, Sao Paulo State University, Unesp, Araçatuba/SP
Araçatuba, São Paulo, 16025-050

Other trials in Brazil

About this study

Official title: Epstein-Barr Detection in Squamous Cell Carcinoma and Healthy Oral Mucosa

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).

Read the 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.

Conditions: Oral Cancer
Keywords: oral cancer, EBV, PCR
Medical subject headings: Mouth Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01039272
Study group	Role	What they receive
oral cancer		patients with oral squamous cell carcinoma
control group		healthy patients without any oral pathology

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Jun 2015

First posted24 Dec 2009 (estimated)
Study startMar 2008
Primary completionApr 2008
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Oral CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Cross-sectional
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01039272
Sponsor's protocol ID: upeclin/FOA-Unesp-03
Status last verified: Jun 2015
First submitted: 22 Dec 2009
Last updated: 25 Jun 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma

All Oral Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Epstein-Barr Detection in Squamous Cell Carcinoma and Healthy Oral Mucosa
ClinicalTrials.gov ID: NCT01039272
Acronym / sponsor ID: upeclin/FOA-Unesp-03
Conditions: Oral Cancer
Keywords: oral cancer, EBV, PCR
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: UPECLIN HC FM Botucatu UnespUniversity, hospital or other
Study start: Mar 2008
Primary completion: Apr 2008 (actual)
Study completion: Jun 2015 (actual)
First posted: 24 Dec 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case-control
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
oral cancer	–	–patients with oral squamous cell carcinoma
control group	–	–healthy patients without any oral pathology

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: oral care clinic, community sample

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

without oral squamous cell carcinoma

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
School of Dentistry, Sao Paulo State University, Unesp, Araçatuba/SPLink provided by the sponsor.

Related trials for Oral Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Glauco Issamu I Miyahara, Professor principal investigator

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

Lívia T Arêde, student study chair

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Oral Cancer, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

presence of EBV (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01039272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.