A Study of Tooth Erosion in People With Esophagogastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Dental Erosion as a Non-invasive Biomarker of Esophagogastric Cancer

Conditions
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Esophagogastric Cancer

Intervention / Treatment
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* Other: Survey
* Other: Intra-oral camera
* Other: Optional Salvia sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients without molars or with significant molar dental work precluding dentists from assessing enamel status. For healthy controls only, patients cannot have a non-skin cancer history nor presenting for a procedure evaluating reflux symptoms.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients will complete a questionnaire and undergo imaging by the intra-oral camera of their teeth.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients diagnosed with esophagogastric cancer<br>Patients have completed the intervention once completing the survey, undergoing dental imaging and future patients will also provide an optional saliva sample. | Other: Survey<br>* 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.<br>Other: Intra-oral camera<br>* Intraoral pictures of molars and incisors in 13 key regions<br>Other: Optional Salvia sample<br>* Cohort 1 only. Participant is responsible for collecting and bringing the salvia sample to clinic.<br>|
| Experimental: Patients diagnosed with colorectal, pancreatic, breast, head and neck, or non-small cell lung cancer<br>Patients undergo consenting and dental imaging during their routine visits at MSK. | Other: Survey<br>* 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.<br>Other: Intra-oral camera<br>* Intraoral pictures of molars and incisors in 13 key regions<br>|
| Experimental: Healthy volunteers who have not been diagnosed with cancer<br>Healthy controls will be defined as those without a known or suspected cancer history and excluding those undergoing a procedure for symptomatic reflux. | Other: Survey<br>* 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.<br>Other: Intra-oral camera<br>* Intraoral pictures of molars and incisors in 13 key regions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of dental erosions | scored with a modified BEWE index. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth erosion, GERD, Loss of tooth enamel, 22-370