A Study of Tooth Erosion in People With Esophagogastric Cancer

Esophagogastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05612048
• Other study ID #: 22-370
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: November 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Steven Maron, MD
• Phone: 646-888-6780
• Email: marons[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 healthy volunteer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophagogastric Cancer
• Tooth Erosion

Intervention

Other:
• 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.
• Intra-oral camera
Intraoral pictures of molars and incisors in 13 key regions
• Optional Salvia sample
Cohort 1 only. Participant is responsible for collecting and bringing the salvia sample to clinic.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of dental erosions	scored with a modified BEWE index.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center