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CompletedNCT01043328CDHPOTSSUpdated Mar 26, 2013

Human Papillomavirus on Oral Tissue, Saliva and Serum

An observational study in Squamous Cell Carcinoma, sponsored by UPECLIN HC FM Botucatu Unesp. Completed at 1 site in Brazil. Open to participants aged 30 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-26.

Sponsored by UPECLIN HC FM Botucatu Unesp · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
80
Ages
30 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

This study will made at the buccal cancer center of UNESP and involved forty patients (n = 40) and forty controls. Serum samples, oral swabs and saliva will collect at the date of diagnosis before therapy and will store at -80 ºC until analysis. Formalin-fixed paraffin-embedded oral squamous cell carcinoma tissues and other biologic samples will process with phenol/chloroform extraction method.

Tumors from 40 OSCC patients at the UNESP University will be obtained from biopsy with prior consent, along with corresponding venipuncture blood, saliva collection and exfoliated buccal cells samples. From controls will be obtained all samples except biopsy tissues. Clinical information including tumor location, stage, and nodal status will be recorded.

Clotted blood specimens will be centrifuged at low speed for 5 min, and the serum was stored at - 80 °C before DNA extraction. Serum samples (400 ml) will be used for DNA extraction. Whole saliva and exfoliated buccal cells will be digested in proteinase K at 48°C during two hours, serum and tumor tissue samples will be digested in proteinase K at 48°C overnight, followed by phenol/chloroform extraction and ethanol precipitation of DNA for all samples. After resuspension in 50 ml of distilled water, the mean working DNA concentrations will be 100-150 ng/ml per serum and tissues samples and 30-50 ng/ ml per whole saliva and exfoliated buccal cells samples. For beta-globin PCR will be used 150 to 300 ng of purified total cellular DNA, to assess the quality of the DNA using the PCR primers GH20 and PC04. After confirmation of the presence and integrity of genomic human DNA, the same amount of DNA will be testing for HPV DNA by nested polymerase chain reaction (PCR) in all samples. In first PCR round degenerate consensus primers MY11 and MY09 will be using to amplify fragments of 450 bp. HPV DNA will amplified in a second round by GP5+ and GP6+ primer sets. The other reaction components will be: 10.9 microlitres of ultra-pure water, 2.5 microlitres PCR buffer 10X, 4mM MgCl2, 15 pmol dNTPs and 1 unit of Platinum Taq DNA polymerase. Approximately 150-300 ng of genomic DNA from each sample will be add to the mixture. The same amount of Hela cells, with up to 4 copies of HPV-18 per cell, will be used as positive control for HPV infection. The negative control will be composed by all PCR components except DNA. The mixture underwent initial denaturation to 94ºC for 10 min, before 40 PCR cycles (94ºC for 1 min; 55ºC for 1 min; 72ºC for 40) and 72°C for 4 minutes. For nPCR, two microliters of the product from the first reaction will be used directly in a reaction containing: 0,02 mM of each primer GP5+ and GP6+(Invitrogen Life Technologies®, Brazil), which produce a 150 pb DNA fragment. The remaining reaction components and conditions will be as described for the first round of PCR, except for the annealing temperature that will be reduced to 43ºC. Ten microliters of the nPCR products will be fractionated by electrophoresis in a 8% polyacrylamide gel, for 3 hours at 100 volts. Band visualization will be performed by staining with silver nitrate solution. Samples will be scored as either HPV DNA-positive or negative based on the inspection of silver nitrate stained bands. PCR amplification will be performed in triplicates for each sample. Samples will be classified as positive or negative based on gel analysis.

Differences in proportion will be evaluated by means of Fisher's exact test. A P value of less then 0.05 will be considered statistically significant. These statistical calculations will be performed using SPSS, version 10.0, for Windows.

02

Conditions studied

  • Squamous Cell Carcinoma

Keywords

  • human papillomavirus
  • nested PCR
  • saliva
  • serum
  • oral tissues
03

In context

Carcinoma, Squamous Cell

1,779 studies on the registry are indexed under Carcinoma, Squamous Cell; 409 are open to participants now.

This study's enrollment of 80 is below the median of 100 across 271 observational studies indexed under Carcinoma, Squamous Cell.

Browse Carcinoma, Squamous Cell studies →

Lead sponsor

UPECLIN HC FM Botucatu Unesp is the lead sponsor of 65 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

university dental care clinic patients with or without a condition

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients that received radiotherapy.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
80 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. DNA HPV status (positive/negative)

    Time frame: six months

Secondary outcomes

  1. clinical and pathological characteristics

    Time frame: six months

07

Study locations

1 site
  • Glauco Issamu Miyahara
    Araçatuba, São Paulo 16015050, Brazil
08

References and documents

Publications

  • 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. PubMed 16272465 ↗
  • 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. PubMed 15929076 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01043328
Lead sponsor
UPECLIN HC FM Botucatu Unesp
Responsible party
Adriana Demathé (PhD Adriana Demathe, UPECLIN HC FM Botucatu Unesp) — Principal investigator
First posted
Jan 6, 2010
Start date
May 2009
Primary completion
Jan 2010
Completion
Dec 2010
Last update
Mar 26, 2013

Study contacts

Adriana Demathe, PhD
principal investigator · UNESP Dental School
Glauco I Miyahara, PhD
study director · UNESP Dental School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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