- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03418454
The Oral Microbiome as a Prognostic Tool in Oral Malignant and Premalignant Lesions and in Medication Related Osteonecrosis of the Jaw
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Irit Allon, MD, Phd
- Phone Number: 972-52-3609727
- Email: irital@bmc.gov.il
Study Locations
-
-
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Ashkelon, Israel
- Recruiting
- Barzilai Medical Center
-
Contact:
- Irit Alon, MD, Phd
- Phone Number: 972-52-3609727
- Email: irital@bmc.gov.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients biopsied with OSCC
- Patients biopsied with oral premalignant lesions
- Patients biopsied with osteonecrosis of the jaw
- healthy age matched patients that visit the oral and maxillofacial clinic for other purposes such as extraction, reactive lesions
Exclusion Criteria:
- Patients receiving antimicrobial treatment in the previous 3 months
- Patients receiving radiotherapy
- Patients receiving chemo/immunotherapy
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Oral Squamous Cell Carcinoma
Buccal mucosa samples for Extraction of BACTERIAL DNA
|
Sampling of the buccal mucosa after informed consent and prior to routine treatment. Similar sampling on follow up after 3,6,9,12 months. Extracted BACTERIAL DNA (and not human DNA) from clinical samples will be sequenced and analyzed for the 16s rRNA (BACTERIAL ribosome). |
Oral Epithelial Dysplasia
Buccal mucosa samples for Extraction of BACTERIAL DNA
|
Sampling of the buccal mucosa after informed consent and prior to routine treatment. Similar sampling on follow up after 3,6,9,12 months. Extracted BACTERIAL DNA (and not human DNA) from clinical samples will be sequenced and analyzed for the 16s rRNA (BACTERIAL ribosome). |
Control: Healthy age matched patients
Buccal mucosa samples for Extraction of BACTERIAL DNA
|
Sampling of the buccal mucosa after informed consent and prior to routine treatment. Similar sampling on follow up after 3,6,9,12 months. Extracted BACTERIAL DNA (and not human DNA) from clinical samples will be sequenced and analyzed for the 16s rRNA (BACTERIAL ribosome). |
Osteonecrosis of the Jaw
Buccal mucosa samples for Extraction of BACTERIAL DNA
|
Sampling of the buccal mucosa after informed consent and prior to routine treatment. Similar sampling on follow up after 3,6,9,12 months. Extracted BACTERIAL DNA (and not human DNA) from clinical samples will be sequenced and analyzed for the 16s rRNA (BACTERIAL ribosome). |
Underlying disease, no necrosis of the jaw
Buccal mucosa samples for Extraction of BACTERIAL DNA
|
Sampling of the buccal mucosa after informed consent and prior to routine treatment. Similar sampling on follow up after 3,6,9,12 months. Extracted BACTERIAL DNA (and not human DNA) from clinical samples will be sequenced and analyzed for the 16s rRNA (BACTERIAL ribosome). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiome characterization day 1 of the study
Time Frame: Day 1 of each participant
|
Extracted BACTERIAL DNA sequenced by amplification of the V4 region of 16s rRNA (BACTERIAL ribosome).
The samples will be obtained by buccal mucosa swabs from all subjects at the clinic visit (day 1).
FLOQ swabs (Copan) will be rubbed on the inner cheek mucosa that looks macroscopically normal.
The swab will be immediately placed in a 15ml polypropylene tube containing 1 ml of Molecular grade PBS.
Samples will be kept at 4oC until frozen at -80oC.
Each sample will be assigned a protocol serial number, de-identified from the subject.
|
Day 1 of each participant
|
Microbiome characterization month 3 of the study
Time Frame: Month 3 of each participant
|
1Extracted BACTERIAL DNA sequenced by amplification of the V4 region of 16s rRNA (BACTERIAL ribosome).
The samples will be obtained by buccal mucosa swabs from all subjects at the clinic visit (month 3).
FLOQ swabs (Copan) will be rubbed on the inner cheek mucosa that looks macroscopically normal.
The swab will be immediately placed in a 15ml polypropylene tube containing 1 ml of Molecular grade PBS.
Samples will be kept at 4oC until frozen at -80oC.
Each sample will be assigned a protocol serial number, de-identified from the subject.
|
Month 3 of each participant
|
Microbiome characterization month 6 of the study
Time Frame: Month 6 of each participant
|
Extracted BACTERIAL DNA sequenced by amplification of the V4 region of 16s rRNA (BACTERIAL ribosome).
The samples will be obtained by buccal mucosa swabs from all subjects at the clinic visit (month 6).
FLOQ swabs (Copan) will be rubbed on the inner cheek mucosa that looks macroscopically normal.
The swab will be immediately placed in a 15ml polypropylene tube containing 1 ml of Molecular grade PBS.
Samples will be kept at 4oC until frozen at -80oC.
Each sample will be assigned a protocol serial number, de-identified from the subject.
|
Month 6 of each participant
|
Microbiome characterization month 9 of the study
Time Frame: Month 9 of each participant
|
Extracted BACTERIAL DNA sequenced by amplification of the V4 region of 16s rRNA (BACTERIAL ribosome).
The samples will be obtained by buccal mucosa swabs from all subjects at the clinic visit (month 9).
FLOQ swabs (Copan) will be rubbed on the inner cheek mucosa that looks macroscopically normal.
The swab will be immediately placed in a 15ml polypropylene tube containing 1 ml of Molecular grade PBS.
Samples will be kept at 4oC until frozen at -80oC.
Each sample will be assigned a protocol serial number, de-identified from the subject.
|
Month 9 of each participant
|
Microbiome characterization month 12 of the study
Time Frame: Month 12 of each participant
|
3. Extracted BACTERIAL DNA sequenced by amplification of the V4 region of 16s rRNA (BACTERIAL ribosome).
The samples will be obtained by buccal mucosa swabs from all subjects at the clinic visit (month 12).
FLOQ swabs (Copan) will be rubbed on the inner cheek mucosa that looks macroscopically normal.
The swab will be immediately placed in a 15ml polypropylene tube containing 1 ml of Molecular grade PBS.
Samples will be kept at 4oC until frozen at -80oC.
Each sample will be assigned a protocol serial number, de-identified from the subject.
|
Month 12 of each participant
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Human Microbiome Project Consortium. Structure, function and diversity of the healthy human microbiome. Nature. 2012 Jun 13;486(7402):207-14. doi: 10.1038/nature11234.
- D'Souza G, Kreimer AR, Viscidi R, Pawlita M, Fakhry C, Koch WM, Westra WH, Gillison ML. Case-control study of human papillomavirus and oropharyngeal cancer. N Engl J Med. 2007 May 10;356(19):1944-56. doi: 10.1056/NEJMoa065497.
- Speight PM. Update on oral epithelial dysplasia and progression to cancer. Head Neck Pathol. 2007 Sep;1(1):61-6. doi: 10.1007/s12105-007-0014-5. Epub 2007 Nov 30. No abstract available.
- Ding T, Schloss PD. Dynamics and associations of microbial community types across the human body. Nature. 2014 May 15;509(7500):357-60. doi: 10.1038/nature13178. Epub 2014 Apr 16.
- Bagan JV, Scully C. Recent advances in Oral Oncology 2007: epidemiology, aetiopathogenesis, diagnosis and prognostication. Oral Oncol. 2008 Feb;44(2):103-8. doi: 10.1016/j.oraloncology.2008.01.008.
- Camisasca DR, Silami MA, Honorato J, Dias FL, de Faria PA, Lourenco Sde Q. Oral squamous cell carcinoma: clinicopathological features in patients with and without recurrence. ORL J Otorhinolaryngol Relat Spec. 2011;73(3):170-6. doi: 10.1159/000328340. Epub 2011 May 27.
- Lindenblatt Rde C, Martinez GL, Silva LE, Faria PS, Camisasca DR, Lourenco Sde Q. Oral squamous cell carcinoma grading systems--analysis of the best survival predictor. J Oral Pathol Med. 2012 Jan;41(1):34-9. doi: 10.1111/j.1600-0714.2011.01068.x. Epub 2011 Sep 8.
- Dietert RR, Silbergeld EK. Biomarkers for the 21st century: listening to the microbiome. Toxicol Sci. 2015 Apr;144(2):208-16. doi: 10.1093/toxsci/kfv013. Epub 2015 Mar 20.
- Li K, Bihan M, Yooseph S, Methe BA. Analyses of the microbial diversity across the human microbiome. PLoS One. 2012;7(6):e32118. doi: 10.1371/journal.pone.0032118. Epub 2012 Jun 13.
- Meyer MS, Joshipura K, Giovannucci E, Michaud DS. A review of the relationship between tooth loss, periodontal disease, and cancer. Cancer Causes Control. 2008 Nov;19(9):895-907. doi: 10.1007/s10552-008-9163-4. Epub 2008 May 14.
- Fitzpatrick SG, Katz J. The association between periodontal disease and cancer: a review of the literature. J Dent. 2010 Feb;38(2):83-95. doi: 10.1016/j.jdent.2009.10.007. Epub 2009 Nov 4.
- Ahn J, Segers S, Hayes RB. Periodontal disease, Porphyromonas gingivalis serum antibody levels and orodigestive cancer mortality. Carcinogenesis. 2012 May;33(5):1055-8. doi: 10.1093/carcin/bgs112. Epub 2012 Feb 26.
- Yu G, Gail MH, Shi J, Klepac-Ceraj V, Paster BJ, Dye BA, Wang GQ, Wei WQ, Fan JH, Qiao YL, Dawsey SM, Freedman ND, Abnet CC. Association between upper digestive tract microbiota and cancer-predisposing states in the esophagus and stomach. Cancer Epidemiol Biomarkers Prev. 2014 May;23(5):735-41. doi: 10.1158/1055-9965.EPI-13-0855. Epub 2014 Apr 3.
- Meurman JH, Uittamo J. Oral micro-organisms in the etiology of cancer. Acta Odontol Scand. 2008;66(6):321-6. doi: 10.1080/00016350802446527. Erratum In: Acta Odontol Scand. 2009;67(4):256.
- Meurman JH. Oral microbiota and cancer. J Oral Microbiol. 2010 Aug 10;2. doi: 10.3402/jom.v2i0.5195.
- Nagy KN, Sonkodi I, Szoke I, Nagy E, Newman HN. The microflora associated with human oral carcinomas. Oral Oncol. 1998 Jul;34(4):304-8.
- Pushalkar S, Ji X, Li Y, Estilo C, Yegnanarayana R, Singh B, Li X, Saxena D. Comparison of oral microbiota in tumor and non-tumor tissues of patients with oral squamous cell carcinoma. BMC Microbiol. 2012 Jul 20;12:144. doi: 10.1186/1471-2180-12-144.
- Schmidt BL, Kuczynski J, Bhattacharya A, Huey B, Corby PM, Queiroz EL, Nightingale K, Kerr AR, DeLacure MD, Veeramachaneni R, Olshen AB, Albertson DG. Changes in abundance of oral microbiota associated with oral cancer. PLoS One. 2014 Jun 2;9(6):e98741. doi: 10.1371/journal.pone.0098741. eCollection 2014. Erratum In: PLoS One. 2014;9(8):e106297. Muy-Teck The [removed].
- Ahn J, Chen CY, Hayes RB. Oral microbiome and oral and gastrointestinal cancer risk. Cancer Causes Control. 2012 Mar;23(3):399-404. doi: 10.1007/s10552-011-9892-7. Epub 2012 Jan 22.
- Guerrero-Preston R, Godoy-Vitorino F, Jedlicka A, Rodriguez-Hilario A, Gonzalez H, Bondy J, Lawson F, Folawiyo O, Michailidi C, Dziedzic A, Thangavel R, Hadar T, Noordhuis MG, Westra W, Koch W, Sidransky D. 16S rRNA amplicon sequencing identifies microbiota associated with oral cancer, human papilloma virus infection and surgical treatment. Oncotarget. 2016 Aug 9;7(32):51320-51334. doi: 10.18632/oncotarget.9710.
- Sedghizadeh PP, Yooseph S, Fadrosh DW, Zeigler-Allen L, Thiagarajan M, Salek H, Farahnik F, Williamson SJ. Metagenomic investigation of microbes and viruses in patients with jaw osteonecrosis associated with bisphosphonate therapy. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Dec;114(6):764-70. doi: 10.1016/j.oooo.2012.08.444.
- Kolenbrander PE, Andersen RN, Blehert DS, Egland PG, Foster JS, Palmer RJ Jr. Communication among oral bacteria. Microbiol Mol Biol Rev. 2002 Sep;66(3):486-505, table of contents. doi: 10.1128/MMBR.66.3.486-505.2002.
- Ribeiro GH, Chrun ES, Dutra KL, Daniel FI, Grando LJ. Osteonecrosis of the jaws: a review and update in etiology and treatment. Braz J Otorhinolaryngol. 2017 Jun 24;84(1):102-8. doi: 10.1016/j.bjorl.2017.05.008. Online ahead of print.
- Voss PJ, Poxleitner P, Schmelzeisen R, Stricker A, Semper-Hogg W. Update MRONJ and perspectives of its treatment. J Stomatol Oral Maxillofac Surg. 2017 Sep;118(4):232-235. doi: 10.1016/j.jormas.2017.06.012. Epub 2017 Jul 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRZ 0062-17 CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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