Oral CancerNCT03304132
The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer
An observational study of Oral Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
The human oral cavity is a diverse habitat that contains approximately 700 prokaryotic species. The oral microbiome is comprised of 44% named species, 12% isolates representing unnamed species, and 44% phylotypes known only from 16S rRNA based cloning studies (http://www.homd.org/). Read more about this study
- Who is it for?
- Ages 40 to 92 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach and Classification of Oral Microbiome Using taxonomic approach
- Type of treatment
- Pill or oral medicine
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 1992to 1 Dec 2010
- 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 to 92 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The American Cancer Society Cancer (ACS) Prevention Study II Nutrition Cohort (CPS-II) was established in 1992; the cohort includes over 86,000 men and 97,000 women from 21 U.S. states who completed a mailed questionnaire in 1992. In total, 72 UADSCC were eligible for study, with completed informed consent and prediagnostic oral wash collection. The Prostate, Lung, Colon and Ovarian (PLCO) Cancer Screening Trial is a randomized controlled trial of approximately 155,000 men and women. Participants are randomized to either a screening or control arm. n total, 68 UADSCC were eligible for study, including completed informed consent and prediagnostic oral wash collection.
Who may be able to join
- Diagnosis of Upper Aerodigestive Squamous Cell Cancer and registered in:
- The American Cancer Society Cancer Prevention Study II (CPS-II)
- The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The human oral cavity is a diverse habitat that contains approximately 700 prokaryotic species. The oral microbiome is comprised of 44% named species, 12% isolates representing unnamed species, and 44% phylotypes known only from 16S rRNA based cloning studies (http://www.homd.org/). Species from 11 phyla have been identified: Firmicutes, Bacteroidetes, Proteobacteria, Actinobacteria, Spirochaetes, Fusobacteria, TM7, Synergistetes, Chlamydiae, Chloroflexi and SR1 (http://www.homd.org/). Because these observations have been mainly based on data generated from traditional Sanger sequencing, the diversity of oral microbiome is highly likely underestimated. Application of high throughput sequencing to the oral microbiome similar to the scale of the microbiome studies of other body sites (GI tract, skin, and vagina) under the Human Microbiome Project is necessary to obtain data essential for understanding the diversity and community structure of the oral microbiome in health and disease.
Read the detailed description
The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial and The American Cancer Society Cancer Prevention Study II (CPS-II) investigators have identified 140 UADSCC cases that have been frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO), gender, ethnic background, and age, within 10 years.
- Conditions
- Oral Cancer
- Being tested
- Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach, Classification of Oral Microbiome Using taxonomic approach
- Keywords
- Oral Microbiome, reflux disorders, esophageal microbiome, Alcohol Use, Tobacco Use
- Medical subject headings
- Mouth Neoplasms, Alcohol Drinking, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classification of Oral Microbiome Using 16S rRNA gene sequence-based approachOther
The sequence-based approach is selected because it classifies samples by considering the entire difference (genetic distance) in 16S rRNA gene sequences among samples analyzed, unbiased by artificial details such as taxonomies, sequence length, or even quality scores.
Classification of Oral Microbiome Using taxonomic approachOther
The taxonomic approach is a complement to the sequence-based approach in that it will further identify specific taxonomic groups or species that can explain the difference found by overall analyses.
| Study group | Role | What they receive |
|---|---|---|
| Upper aerodigestive squamous cell cancers (UADSCC) cases | From PLCO and ACS CPS II, identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO), Receives: Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach; Other: Classification of Oral Microbiome Using taxonomic approach | |
| Controls | From PLCO and ACS CPS II, we have identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO), Receives: Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach; Other: Classification of Oral Microbiome Using taxonomic approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
16S rRNA gene survey approach for microbiome characterization
Data alignment and clustering to determine microbiome species diversity
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start1 Dec 1992
- Primary completion1 Dec 2010
- Study completion1 Dec 2010
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.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jiyoung Ahn, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304132
- Sponsor's protocol ID
- 10-01834
- Status last verified
- Oct 2017
- First submitted
- 3 Oct 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT03304132
- Acronym / sponsor ID
- 10-01834
- Conditions
- Oral Cancer
- Keywords
- Oral Microbiome, reflux disorders, esophageal microbiome, Alcohol Use, Tobacco Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Dec 1992 (actual)
- Primary completion
- 1 Dec 2010 (actual)
- Study completion
- 1 Dec 2010 (actual)
- First posted
- 6 Oct 2017 (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.
The human oral cavity is a diverse habitat that contains approximately 700 prokaryotic species. The oral microbiome is comprised of 44% named species, 12% isolates representing unnamed species, and 44% phylotypes known only from 16S rRNA based cloning studies (http://www.homd.org/). Species from 11 phyla have been identified: Firmicutes, Bacteroidetes, Proteobacteria, Actinobacteria, Spirochaetes, Fusobacteria, TM7, Synergistetes, Chlamydiae, Chloroflexi and SR1 (http://www.homd.org/). Because these observations have been mainly based on data generated from traditional Sanger sequencing, the diversity of oral microbiome is highly likely underestimated. Application of high throughput sequencing to the oral microbiome similar to the scale of the microbiome studies of other body sites (GI tract, skin, and vagina) under the Human Microbiome Project is necessary to obtain data essential for understanding the diversity and community structure of the oral microbiome in health and disease.
Detailed description
The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial and The American Cancer Society Cancer Prevention Study II (CPS-II) investigators have identified 140 UADSCC cases that have been frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO), gender, ethnic background, and age, within 10 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper aerodigestive squamous cell cancers (UADSCC) cases | – | Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach, Other: Classification of Oral Microbiome Using taxonomic approachFrom PLCO and ACS CPS II, identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO), |
| Controls | – | Other: Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach, Other: Classification of Oral Microbiome Using taxonomic approachFrom PLCO and ACS CPS II, we have identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO), |
Who may qualify
- Ages
- 40 to 92 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The American Cancer Society Cancer (ACS) Prevention Study II Nutrition Cohort (CPS-II) was established in 1992; the cohort includes over 86,000 men and 97,000 women from 21 U.S. states who completed a mailed questionnaire in 1992. In total, 72 UADSCC were eligible for study, with completed informed consent and prediagnostic oral wash collection. The Prostate, Lung, Colon and Ovarian (PLCO) Cancer Screening Trial is a randomized controlled trial of approximately 155,000 men and women. Participants are randomized to either a screening or control arm. n total, 68 UADSCC were eligible for study, including completed informed consent and prediagnostic oral wash collection.
Key inclusion criteria (3 listed)
- Diagnosis of Upper Aerodigestive Squamous Cell Cancer and registered in:
- The American Cancer Society Cancer Prevention Study II (CPS-II)
- The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Classification of Oral Microbiome Using 16S rRNA gene sequence-based approachThe sequence-based approach is selected because it classifies samples by considering the entire difference (genetic distance) in 16S rRNA gene sequences among samples analyzed, unbiased by artificial details such as taxonomies, sequence length, or even quality scores. | Other | Controls, Upper aerodigestive squamous cell cancers (UADSCC) cases |
| Classification of Oral Microbiome Using taxonomic approachThe taxonomic approach is a complement to the sequence-based approach in that it will further identify specific taxonomic groups or species that can explain the difference found by overall analyses. | Other | Controls, Upper aerodigestive squamous cell cancers (UADSCC) cases |
Primary outcome
16S rRNA gene survey approach for microbiome characterization
Time frame: 4 Years
Data alignment and clustering to determine microbiome species diversity
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 9 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Jiyoung Ahn, MD principal investigator
NYU Langone Health
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 NYU Langone Health at 1 site in United States.
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 3 inclusion and 0 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 9 Oct 2017. 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 United States. 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?
16S rRNA gene survey approach for microbiome characterization (time frame: 4 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2017.