Oral Squamous Cell CarcinomaNCT03418454
The Oral Microbiome as a Prognostic Tool in Oral Malignant and Premalignant Lesions and in Medication Related Osteonecrosis of the Jaw
An observational study of Oral Squamous Cell Carcinoma and Medication Related Osteonecrosis of the Jaw, run by Barzilai Medical Center at 1 site in Israel.
Trial summary
Oral squamous cell carcinoma (OSCC) is the most common malignant tumor of the head and neck, and its incidence has increased in recent years. Extensive surgery with neck dissection and chemo/radio/ targeted therapy is the current treatment for OSCC, and despite great progress in chemotherapy, radiotherapy, and… Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Squamous Cell Carcinoma, Medication Related Osteonecrosis of the Jaw, Oral Epithelial Dysplasia
- What is being tested?
- Buccal mucosa samples for Extraction of BACTERIAL DNA
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Dec 2017to 31 Dec 2021
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be selected from the Oral \& Maxillofacial Surgery outpatient Clinique at the Barzilai Medical Center, Ashkelon, Israel
Who may be able to join
- 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
Who cannot join
- Patients receiving antimicrobial treatment in the previous 3 months
- Patients receiving radiotherapy
- Patients receiving chemo/immunotherapy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Barzilai medical Center
Ashkelon
Irit Alon, MD, Phd, 972-52-3609727, irital@bmc.gov.il
About this study
Oral squamous cell carcinoma (OSCC) is the most common malignant tumor of the head and neck, and its incidence has increased in recent years. Extensive surgery with neck dissection and chemo/radio/ targeted therapy is the current treatment for OSCC, and despite great progress in chemotherapy, radiotherapy, and targeted therapy in the last three decades, the prognosis of OSCC is still poor due to aggressive local invasion and metastasis, which lead to recurrence. Postoperative tumor recurrence confers a poor prognosis in OSCC and a poor quality of life. The 5-year survival rate is over 90% in OSCC patients without recurrence and 30% in patients with recurrence, with a median survival of 76.8 months in patients without recurrence and 42.5 months in patients with recurrence . Therefore, it is important to identify biomarkers that may predict the postoperative recurrence of OSCC. Also, some of the OSCC are preceded by precursor lesions. In the oral cavity the most common lesions recognized as potentially malignant are leukoplakia and erythroplakia, but it is also apparent that as many as 50% of OSCC arise from apparently clinically normal mucosa. The prognostic significance of an individual lesion is difficult to determine. At present therefore, the gold standard for the assessment of oral potentially malignant lesions is microscopic evaluation of haematoxylin and eosin stained sections for the presence of architectural and cytological changes, which are generally referred to as oral epithelial dysplasia (OED). The human microbiome is defined as the collective genomes of the microbes (composed of bacteria, bacteriophages, fungi, protozoa and viruses) that live inside and on the human body, and there are approximately 10 microbes and 100 microbial genes for each human cell and gene respectively. With the advent of next generation sequencing technology, the Human Microbiome Project delineated the composition of healthy microbial communities associated to different body sites in healthy individuals, including the oral cavity [Human microbiome consortium]. As opposed to a normal (healthy) microbiome, a disrupted microbiome or dysbiosis represents the lack of equilibrium, and is hypothetically related to disease. Interestingly, the healthy oral microbiome shows relative intraindividual stability over time, suggesting that differences in microbiome profiles may serve as useful tools for the identification of disease states. The working hypothesis is that in OSCC patients, the oral microbiome is altered in comparison to healthy individuals and certain microbial signatures are characteristic of healthy versus disease. In addition, in precursor conditions, i.e., oral epithelial dysplasia (OED), a partial alteration in the composition of the microbiome may predict the progression to malignancy.Also, during treatment, it could be that specific microbial signatures are associated with incomplete eradication, tendency to local recurrence or metastatic potential.Correlations to local recurrence (LR), distant metastases (DM) or disease free survival (DFS) adjusted to clinicopathologic correlations will be sought. In this study, buccal mucosa samples will be collected from patients with OSCC, OED and from healthy individuals , after signing for informed consent, according to Helsinki protocol. Routine pathologic diagnosis will be performed by expert Pathology physicians in our center. Data will be correlated to demographic and clinical data obtained from medical records. This will be carried out in line with institutional ethical guidelines.
- Conditions
- Oral Squamous Cell Carcinoma, Medication Related Osteonecrosis of the Jaw, Oral Epithelial Dysplasia
- Being tested
- Buccal mucosa samples for Extraction of BACTERIAL DNA
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buccal mucosa samples for Extraction of BACTERIAL DNADiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Oral Squamous Cell Carcinoma | Buccal mucosa samples for Extraction of BACTERIAL DNA Receives: Diagnostic Test: Buccal mucosa samples for Extraction of BACTERIAL DNA | |
| Oral Epithelial Dysplasia | Buccal mucosa samples for Extraction of BACTERIAL DNA Receives: Diagnostic Test: Buccal mucosa samples for Extraction of BACTERIAL DNA | |
| Control: Healthy age matched patients | Buccal mucosa samples for Extraction of BACTERIAL DNA Receives: Diagnostic Test: Buccal mucosa samples for Extraction of BACTERIAL DNA | |
| Osteonecrosis of the Jaw | Buccal mucosa samples for Extraction of BACTERIAL DNA Receives: Diagnostic Test: Buccal mucosa samples for Extraction of BACTERIAL DNA | |
| Underlying disease, no necrosis of the jaw | Buccal mucosa samples for Extraction of BACTERIAL DNA Receives: Diagnostic Test: Buccal mucosa samples for Extraction of BACTERIAL DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome characterization day 1 of the study
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.
Measured: Day 1 of each participant
Microbiome characterization month 3 of the study
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.
Measured: Month 3 of each participant
Microbiome characterization month 6 of the study
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.
Measured: Month 6 of each participant
Microbiome characterization month 9 of the study
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.
Measured: Month 9 of each participant
Microbiome characterization month 12 of the study
- 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.
Measured: Month 12 of each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start14 Dec 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Oral Squamous Cell CarcinomaStudies 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irit Allon, Barzilai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418454
- Sponsor's protocol ID
- BRZ 0062-17 CTIL
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18252251Camisasca 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.
PubMed 21625192Lindenblatt 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.
PubMed 21902722Dietert 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.
PubMed 25795652Human Microbiome Project Consortium. Structure, function and diversity of the healthy human microbiome. Nature. 2012 Jun 13;486(7402):207-14. doi: 10.1038/nature11234.
PubMed 22699609Li 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.
PubMed 22719823Ding 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.
PubMed 24739969Meyer 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.
PubMed 18478344Fitzpatrick 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.
PubMed 19895866Ahn 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.
PubMed 22367402Yu 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.
PubMed 24700175D'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.
PubMed 17494927Meurman JH, Uittamo J. Oral micro-organisms in the etiology of cancer. Acta Odontol Scand. 2008;66(6):321-6. doi: 10.1080/00016350802446527.
PubMed 18821087Meurman JH. Oral microbiota and cancer. J Oral Microbiol. 2010 Aug 10;2. doi: 10.3402/jom.v2i0.5195.
PubMed 21523227Nagy KN, Sonkodi I, Szoke I, Nagy E, Newman HN. The microflora associated with human oral carcinomas. Oral Oncol. 1998 Jul;34(4):304-8.
PubMed 9813727
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oral Microbiome as a Prognostic Tool in Oral Malignant and Premalignant Lesions and in Medication Related Osteonecrosis of the Jaw
- ClinicalTrials.gov ID
- NCT03418454
- Acronym / sponsor ID
- BRZ 0062-17 CTIL
- Conditions
- Oral Squamous Cell Carcinoma, Medication Related Osteonecrosis of the Jaw, Oral Epithelial Dysplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Feb 2018 (actual)
- 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.
Oral squamous cell carcinoma (OSCC) is the most common malignant tumor of the head and neck, and its incidence has increased in recent years. Extensive surgery with neck dissection and chemo/radio/ targeted therapy is the current treatment for OSCC, and despite great progress in chemotherapy, radiotherapy, and targeted therapy in the last three decades, the prognosis of OSCC is still poor due to aggressive local invasion and metastasis, which lead to recurrence. Postoperative tumor recurrence confers a poor prognosis in OSCC and a poor quality of life. The 5-year survival rate is over 90% in OSCC patients without recurrence and 30% in patients with recurrence, with a median survival of 76.8 months in patients without recurrence and 42.5 months in patients with recurrence . Therefore, it is important to identify biomarkers that may predict the postoperative recurrence of OSCC. Also, some of the OSCC are preceded by precursor lesions. In the oral cavity the most common lesions recognized as potentially malignant are leukoplakia and erythroplakia, but it is also apparent that as many as 50% of OSCC arise from apparently clinically normal mucosa. The prognostic significance of an individual lesion is difficult to determine. At present therefore, the gold standard for the assessment of oral potentially malignant lesions is microscopic evaluation of haematoxylin and eosin stained sections for the presence of architectural and cytological changes, which are generally referred to as oral epithelial dysplasia (OED). The human microbiome is defined as the collective genomes of the microbes (composed of bacteria, bacteriophages, fungi, protozoa and viruses) that live inside and on the human body, and there are approximately 10 microbes and 100 microbial genes for each human cell and gene respectively. With the advent of next generation sequencing technology, the Human Microbiome Project delineated the composition of healthy microbial communities associated to different body sites in healthy individuals, including the oral cavity [Human microbiome consortium]. As opposed to a normal (healthy) microbiome, a disrupted microbiome or dysbiosis represents the lack of equilibrium, and is hypothetically related to disease. Interestingly, the healthy oral microbiome shows relative intraindividual stability over time, suggesting that differences in microbiome profiles may serve as useful tools for the identification of disease states. The working hypothesis is that in OSCC patients, the oral microbiome is altered in comparison to healthy individuals and certain microbial signatures are characteristic of healthy versus disease. In addition, in precursor conditions, i.e., oral epithelial dysplasia (OED), a partial alteration in the composition of the microbiome may predict the progression to malignancy.Also, during treatment, it could be that specific microbial signatures are associated with incomplete eradication, tendency to local recurrence or metastatic potential.Correlations to local recurrence (LR), distant metastases (DM) or disease free survival (DFS) adjusted to clinicopathologic correlations will be sought. In this study, buccal mucosa samples will be collected from patients with OSCC, OED and from healthy individuals , after signing for informed consent, according to Helsinki protocol. Routine pathologic diagnosis will be performed by expert Pathology physicians in our center. Data will be correlated to demographic and clinical data obtained from medical records. This will be carried out in line with institutional ethical guidelines.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Oral Squamous Cell Carcinoma | – | Diagnostic Test: Buccal mucosa samples for Extraction of BACTERIAL DNABuccal mucosa samples for Extraction of BACTERIAL DNA |
| Oral Epithelial Dysplasia | – | Diagnostic Test: Buccal mucosa samples for Extraction of BACTERIAL DNABuccal mucosa samples for Extraction of BACTERIAL DNA |
| Control: Healthy age matched patients | – | Diagnostic Test: Buccal mucosa samples for Extraction of BACTERIAL DNABuccal mucosa samples for Extraction of BACTERIAL DNA |
| Osteonecrosis of the Jaw | – | Diagnostic Test: Buccal mucosa samples for Extraction of BACTERIAL DNABuccal mucosa samples for Extraction of BACTERIAL DNA |
| Underlying disease, no necrosis of the jaw | – | Diagnostic Test: Buccal mucosa samples for Extraction of BACTERIAL DNABuccal mucosa samples for Extraction of BACTERIAL DNA |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from the Oral \& Maxillofacial Surgery outpatient Clinique at the Barzilai Medical Center, Ashkelon, Israel
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients receiving antimicrobial treatment in the previous 3 months
- Patients receiving radiotherapy
- Patients receiving chemo/immunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buccal mucosa samples for Extraction of BACTERIAL DNASampling 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). | Diagnostic test | Control: Healthy age matched patients, Oral Epithelial Dysplasia, Oral Squamous Cell Carcinoma, Osteonecrosis of the Jaw, Underlying disease, no necrosis of the jaw |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Background: PubMed 18252251Bagan 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.
- Background: PubMed 21625192Camisasca 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.
- Background: PubMed 21902722Lindenblatt 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.
- Background: PubMed 25795652Dietert 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.
- Background: PubMed 22699609Human Microbiome Project Consortium. Structure, function and diversity of the healthy human microbiome. Nature. 2012 Jun 13;486(7402):207-14. doi: 10.1038/nature11234.
- Background: PubMed 22719823Li 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.
- Background: PubMed 24739969Ding 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.
- Background: PubMed 18478344Meyer 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.
- Background: PubMed 19895866Fitzpatrick 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.
- Background: PubMed 22367402Ahn 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.
- Background: PubMed 24700175Yu 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.
- Background: PubMed 17494927D'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.
- Individual participant dataSharing planned: Undecided
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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.
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 Squamous Cell Carcinoma and Medication Related Osteonecrosis of the Jaw, run by Barzilai Medical Center at 1 site in Israel.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irit Allon, MD, Phd (972-52-3609727, irital@bmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome characterization day 1 of the study (time frame: Day 1 of each participant). The study lists 5 primary outcomes in all. 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 NCT03418454, which also lists 24 linked publications.
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 18 Jan 2020.