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Trial Title:
A Study of Tooth Erosion in People With Esophagogastric Cancer
NCT ID:
NCT05612048
Condition:
Esophagogastric Cancer
Conditions: Official terms:
Tooth Erosion
Conditions: Keywords:
Tooth erosion
GERD
Loss of tooth enamel
22-370
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients will complete a questionnaire and undergo imaging by the intra-oral camera of
their teeth.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Survey
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.
Arm group label:
Healthy volunteers who have not been diagnosed with cancer
Arm group label:
Patients diagnosed with colorectal, pancreatic, breast, head and neck, or non-small cell lung cancer
Arm group label:
Patients diagnosed with esophagogastric cancer
Intervention type:
Other
Intervention name:
Intra-oral camera
Description:
Intraoral pictures of molars and incisors in 13 key regions
Arm group label:
Healthy volunteers who have not been diagnosed with cancer
Arm group label:
Patients diagnosed with colorectal, pancreatic, breast, head and neck, or non-small cell lung cancer
Arm group label:
Patients diagnosed with esophagogastric cancer
Intervention type:
Other
Intervention name:
Optional Salvia sample
Description:
Cohort 1 only. Participant is responsible for collecting and bringing the salvia sample
to clinic.
Arm group label:
Patients diagnosed with esophagogastric cancer
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Steven Maron, MD
Phone:
646-888-6780
Contact backup:
Last name:
Luis Diaz, MD
Phone:
646-888-4641
Start date:
November 3, 2022
Completion date:
November 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05612048
http://www.mskcc.org/mskcc/html/44.cfm
