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A Study of Tooth Erosion in People With Esophagogastric Cancer

Primary Purpose

Esophagogastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Survey
Intra-oral camera
Optional Salvia sample
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Esophagogastric Cancer focused on measuring Tooth erosion, GERD, Loss of tooth enamel, 22-370

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Patients diagnosed with esophagogastric cancer

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

Healthy volunteers who have not been diagnosed with cancer

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The incidence of dental erosions
scored with a modified BEWE index.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2022
Last Updated
August 29, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05612048
Brief Title
A Study of Tooth Erosion in People With Esophagogastric Cancer
Official Title
Pilot Study of Dental Erosion as a Non-invasive Biomarker of Esophagogastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagogastric Cancer
Keywords
Tooth erosion, GERD, Loss of tooth enamel, 22-370

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients will complete a questionnaire and undergo imaging by the intra-oral camera of their teeth.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients diagnosed with esophagogastric cancer
Arm Type
Experimental
Arm Description
Patients have completed the intervention once completing the survey, undergoing dental imaging and future patients will also provide an optional saliva sample.
Arm Title
Patients diagnosed with colorectal, pancreatic, breast, head and neck, or non-small cell lung cancer
Arm Type
Experimental
Arm Description
Patients undergo consenting and dental imaging during their routine visits at MSK.
Arm Title
Healthy volunteers who have not been diagnosed with cancer
Arm Type
Experimental
Arm Description
Healthy controls will be defined as those without a known or suspected cancer history and excluding those undergoing a procedure for symptomatic reflux.
Intervention Type
Other
Intervention Name(s)
Survey
Intervention Description
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
Intervention Name(s)
Intra-oral camera
Intervention Description
Intraoral pictures of molars and incisors in 13 key regions
Intervention Type
Other
Intervention Name(s)
Optional Salvia sample
Intervention Description
Cohort 1 only. Participant is responsible for collecting and bringing the salvia sample to clinic.
Primary Outcome Measure Information:
Title
The incidence of dental erosions
Description
scored with a modified BEWE index.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Maron, MD
Phone
646-888-6780
Email
marons@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Diaz, MD
Phone
646-888-4641
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Maron, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Maron, MD
Phone
646-888-6780
First Name & Middle Initial & Last Name & Degree
Luis Diaz, MD
Phone
646-888-4641

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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A Study of Tooth Erosion in People With Esophagogastric Cancer

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