A Study of Tooth Erosion in People With Esophagogastric Cancer

NCT ID: NCT05612048

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-03
• Study Completion Date: 2026-11-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients diagnosed with esophagogastric cancer

Patients have completed the intervention once completing the survey, undergoing dental imaging and future patients will also provide an optional saliva sample.

Group Type: EXPERIMENTAL

Survey

Intervention Type: 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.

Intra-oral camera

Intervention Type: OTHER

Intraoral pictures of molars and incisors in 13 key regions

Optional Salvia sample

Intervention Type: OTHER

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

Patients diagnosed with colorectal, pancreatic, breast, head and neck, or non-small cell lung cancer

Patients undergo consenting and dental imaging during their routine visits at MSK.

Group Type: EXPERIMENTAL

Survey

Intervention Type: 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.

Intra-oral camera

Intervention Type: OTHER

Intraoral pictures of molars and incisors in 13 key regions

Healthy volunteers who have not been diagnosed with cancer

Healthy controls will be defined as those without a known or suspected invasive cancer history and excluding those undergoing a procedure for symptomatic reflux.

Group Type: EXPERIMENTAL

Survey

Intervention Type: 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.

Intra-oral camera

Intervention Type: OTHER

Intraoral pictures of molars and incisors in 13 key regions

Interventions

Survey

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.

Intervention Type: OTHER

Intra-oral camera

Intraoral pictures of molars and incisors in 13 key regions

Intervention Type: OTHER

Optional Salvia sample

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

Intervention Type: OTHER

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Maron, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Steven Maron, MD

Role: CONTACT

marons@mskcc.org

646-888-6780

Luis Diaz, MD

Role: CONTACT

646-888-4641

Facility Contacts

Steven Maron, MD

Role: primary

646-888-6780

Luis Diaz, MD

Role: backup

646-888-4641

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

22-370

Identifier Type: -

Identifier Source: org_study_id