Esophagogastric CancerNCT05612048
A Study of Tooth Erosion in People With Esophagogastric Cancer
A study testing Survey, Intra-oral camera and Optional Salvia sample in people with Esophagogastric Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The researchers are doing this study to find out more about what may lead to the loss of tooth enamel (the thin outer covering of the tooth) and how often it happens in people with esophagogastric cancer, colorectal cancer, pancreatic cancer, breast cancer, head and neck cancer, or non-small cell lung cancer, or a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Esophagogastric Cancer
- What is being tested?
- Survey, Intra-oral camera and Optional Salvia sample
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is willing and able to provide written informed consent.
- Patients with a history of esophagogastric, HNSCC, PDAC, CRC, or NSCLC or healthy controls
- Patients must be able to fully comprehend and complete the survey and be willing to have pictures taken of their teeth with a camera or intra-oral camera.
- Patients must be able to understand English language or have access to adequate translation services.
- Age ≥ 18 years old.
Who cannot join
- Subjects without evaluable molars or with significant molar dental work precluding dentists from assessing enamel status, Note: evaluable is defined as having bilateral assessable mandibular molars, or erosions present in the remaining assessable quadrants.
- For healthy controls only, patients cannot have a non-skin cancer history nor presenting for a procedure evaluating reflux symptoms.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
About this study
Official title: Pilot Study of Dental Erosion as a Non-invasive Biomarker of Esophagogastric Cancer
The researchers are doing this study to find out more about what may lead to the loss of tooth enamel (the thin outer covering of the tooth) and how often it happens in people with esophagogastric cancer, colorectal cancer, pancreatic cancer, breast cancer, head and neck cancer, or non-small cell lung cancer, or a healthy volunteer.
- Conditions
- Esophagogastric Cancer
- Being tested
- Survey, Intra-oral camera, Optional Salvia sample
- Keywords
- Tooth erosion, GERD, Loss of tooth enamel, 22-370
- Medical subject headings
- Tooth Erosion, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
This is a 15-item questionnaire. The questionnaire asks subjects to quantify, during a specified duration of time, the number of times they have consumed or completed a task (ex. alcohol intake, cigarette use, and teeth brushing frequency). Additionally, the questionnaire further asks subjects to quantify their GERD symptoms and risk factors prior to diagnosis. All study procedures will be completed in one visit as part of a standard-of-care clinic visit.
Intra-oral cameraOther
Intraoral pictures of molars and incisors in 13 key regions
Optional Salvia sampleOther
Cohort 1 only. Participant is responsible for collecting and bringing the salvia sample to clinic.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with esophagogastric cancer | Experimental | Patients have completed the intervention once completing the survey, undergoing dental imaging and future patients will also provide an optional saliva sample. Receives: Other: Survey; Other: Intra-oral camera; Other: Optional Salvia sample |
| Patients diagnosed with colorectal, pancreatic, breast, head and neck, or non-small cell lung cancer | Experimental | Patients undergo consenting and dental imaging during their routine visits at MSK. Receives: Other: Survey; Other: Intra-oral camera |
| Healthy volunteers who have not been diagnosed with cancer | Experimental | Healthy controls will be defined as those without a known or suspected invasive cancer history and excluding those undergoing a procedure for symptomatic reflux. Receives: Other: Survey; Other: Intra-oral camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dental erosions
scored with a modified BEWE index.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start3 Nov 2022
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastric CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will complete a questionnaire and undergo imaging by the intra-oral camera of their teeth.
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Maron, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612048
- Sponsor's protocol ID
- 22-370
- Status last verified
- Mar 2026
- First submitted
- 3 Nov 2022
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Dental Erosion as a Non-invasive Biomarker of Esophagogastric Cancer
- ClinicalTrials.gov ID
- NCT05612048
- Acronym / sponsor ID
- 22-370
- Conditions
- Esophagogastric Cancer
- Keywords
- Tooth erosion, GERD, Loss of tooth enamel, 22-370
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 10 Nov 2022 (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 researchers are doing this study to find out more about what may lead to the loss of tooth enamel (the thin outer covering of the tooth) and how often it happens in people with esophagogastric cancer, colorectal cancer, pancreatic cancer, breast cancer, head and neck cancer, or non-small cell lung cancer, or a healthy volunteer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will complete a questionnaire and undergo imaging by the intra-oral camera of their teeth.
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with esophagogastric cancer | Experimental | Other: Survey, Other: Intra-oral camera, Other: Optional Salvia samplePatients have completed the intervention once completing the survey, undergoing dental imaging and future patients will also provide an optional saliva sample. |
| Patients diagnosed with colorectal, pancreatic, breast, head and neck, or non-small cell lung cancer | Experimental | Other: Survey, Other: Intra-oral cameraPatients undergo consenting and dental imaging during their routine visits at MSK. |
| Healthy volunteers who have not been diagnosed with cancer | Experimental | Other: Survey, Other: Intra-oral cameraHealthy controls will be defined as those without a known or suspected invasive cancer history and excluding those undergoing a procedure for symptomatic reflux. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is willing and able to provide written informed consent.
- Patients with a history of esophagogastric, HNSCC, PDAC, CRC, or NSCLC or healthy controls
- Patients must be able to fully comprehend and complete the survey and be willing to have pictures taken of their teeth with a camera or intra-oral camera.
- Patients must be able to understand English language or have access to adequate translation services.
- Age ≥ 18 years old.
Key exclusion criteria (2 listed)
- Subjects without evaluable molars or with significant molar dental work precluding dentists from assessing enamel status, Note: evaluable is defined as having bilateral assessable mandibular molars, or erosions present in the remaining assessable quadrants.
- For healthy controls only, patients cannot have a non-skin cancer history nor presenting for a procedure evaluating reflux symptoms.
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 |
|---|---|---|
| SurveyThis is a 15-item questionnaire. The questionnaire asks subjects to quantify, during a specified duration of time, the number of times they have consumed or completed a task (ex. alcohol intake, cigarette use, and teeth brushing frequency). Additionally, the questionnaire further asks subjects to quantify their GERD symptoms and risk factors prior to diagnosis. All study procedures will be completed in one visit as part of a standard-of-care clinic visit. | Other | Healthy volunteers who have not been diagnosed with cancer, Patients diagnosed with colorectal, pancreatic, breast, head and neck, or non-small cell lung cancer, Patients diagnosed with esophagogastric cancer |
| Intra-oral cameraIntraoral pictures of molars and incisors in 13 key regions | Other | Healthy volunteers who have not been diagnosed with cancer, Patients diagnosed with colorectal, pancreatic, breast, head and neck, or non-small cell lung cancer, Patients diagnosed with esophagogastric cancer |
| Optional Salvia sampleCohort 1 only. Participant is responsible for collecting and bringing the salvia sample to clinic. | Other | Patients diagnosed with esophagogastric cancer |
Primary outcome
The incidence of dental erosions
Time frame: 1 year
scored with a modified BEWE index.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
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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.
Steven Maron, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey, Intra-oral camera and Optional Salvia sample in people with Esophagogastric Cancer, run by Memorial Sloan Kettering Cancer Center 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The incidence of dental erosions (time frame: 1 year). 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 23 Mar 2026.