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A Study of Tooth Erosion in People With Esophagogastric Cancer

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05612048
Collaborator
(none)
70
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Survey
  • Other: Intra-oral camera
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patients will complete a questionnaire and undergo imaging by the intra-oral camera of their teeth.Patients will complete a questionnaire and undergo imaging by the intra-oral camera of their teeth.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pilot Study of Dental Erosion as a Non-invasive Biomarker of Esophagogastric Cancer
Actual Study Start Date :
Nov 3, 2022
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Survey and Dental imaging

Patients have completed the intervention once completing the survey and undergoing dental imaging.

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.

Other: Intra-oral camera
Intraoral pictures of molars and incisors in 13 key regions

Outcome Measures

Primary Outcome Measures

  1. The incidence of dental erosions [1 year]

    In people with esophagogastric cancer scored with a modified BEWE index.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Subject is willing and able to provide written informed consent.

  • Patients with a history of esophagogastric cancer

  • 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 teeth or significant molar dental work precluding dentists from assessing enamel status.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York United States 10065

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Steven Maron, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT05612048
Other Study ID Numbers:
  • 22-370
First Posted:
Nov 10, 2022
Last Update Posted:
Dec 29, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Tooth erosion
GERD
Loss of tooth enamel
22-370
Additional relevant MeSH terms:
Tooth Erosion

Study Results

No Results Posted as of Dec 29, 2022