Human Papillomavirus on Oral Tissue, Saliva and Serum

NCT01043328 | Completed

• 1 other identifier: upeclin/FOA-Unesp-05
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Human papillomavirus (HPV) is one of the most prevalent infections in the world with several millions of new cases diagnosed yearly. Oral HPV infection may be associated with different diseases of oral cavities including some cases of oropharyngeal cancer. The aim of this report is to detect the presence of HPV DNA in samples of biopsies, oral swabs, saliva and serum of patient with oral squamous cell carcinoma (OSCC) and controls. We hoped to find there is correlation among the presence of HPV DNA in the several biological materials and if it is possible to use the saliva as screening to HPV DNA detection. The presence of tumor HPV DNA in blood may be of diagnostic and prognostic value.

Conditions

Squamous Cell Carcinoma

Keywords

human papillomavirus; nested PCR; saliva; serum; oral tissues

Outcome Measures

Primary Outcomes (1)

• DNA HPV status (positive/negative)

  six months

Secondary Outcomes (1)

• clinical and pathological characteristics

  six months

Study Arms (2)

GROUP OSCC

The study group is composed by patients with a condition that requires a procedure/surgery for oral squamous cell carcinoma treatment. INTERVENTIONS: Collect blood, saliva and oral tissue.

CONTROL GROUP

Group without oral squamous cell carcinoma but with a condition that requires prosthetic procedure/surgery. INTERVENTIONS: Collect blood, saliva and oral tissue.

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

university dental care clinic patients with or without a condition

You may qualify if:

• Pathological diagnosis of squamous cell carcinoma, presented lesions with primary site in the mouth or oropharynx;
• Matched controls without a condition.

You may not qualify if:

• Patients that received radiotherapy.

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead

Study Sites (1)

Glauco Issamu Miyahara

Araçatuba, São Paulo, 16015050, Brazil

Location

Related Publications (2)

• Bodaghi S, Wood LV, Roby G, Ryder C, Steinberg SM, Zheng ZM. Could human papillomaviruses be spread through blood? J Clin Microbiol. 2005 Nov;43(11):5428-34. doi: 10.1128/JCM.43.11.5428-5434.2005.

  PMID: 16272465 BACKGROUND

• Zhao M, Rosenbaum E, Carvalho AL, Koch W, Jiang W, Sidransky D, Califano J. Feasibility of quantitative PCR-based saliva rinse screening of HPV for head and neck cancer. Int J Cancer. 2005 Nov 20;117(4):605-10. doi: 10.1002/ijc.21216.

  PMID: 15929076 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

This biospecimens will be retained: whole blood, exfoliated cells, saliva and formalin-fixed paraffin-embedded tissues.

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Study Officials

• Adriana Demathe, PhD

  UNESP Dental School

  PRINCIPAL INVESTIGATOR

• Glauco I Miyahara, PhD

  UNESP Dental School

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Adriana Demathe

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 6, 2010
• Study Start: May 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 26, 2013

Record last verified: 2013-03

Locations

BR (1)