A Study of Tooth Erosion in People With Esophagogastric Cancer

NCT05612048 | Active Not Recruiting

• 1 other identifier: 22-370
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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 healthy volunteer.

Conditions

Esophagogastric Cancer

Keywords

Tooth erosion; GERD; Loss of tooth enamel; 22-370

Outcome Measures

Primary Outcomes (1)

• The incidence of dental erosions

  scored with a modified BEWE index.

  1 year

Study Arms (3)

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.

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.

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.

Other: Survey; Other: Intra-oral camera

Interventions

Intra-oral camera OTHER

Intraoral pictures of molars and incisors in 13 key regions

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 sample OTHER

Cohort 1 only. Participant is responsible for collecting and bringing the salvia sample to clinic.

Patients diagnosed with esophagogastric cancer

Survey OTHER

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Tooth Erosion; Gastroesophageal Reflux

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Tooth Wear; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Steven Maron, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will complete a questionnaire and undergo imaging by the intra-oral camera of their teeth.

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: November 3, 2022
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)