Dental Health Assessment for Esophageal Cancer

Overseen By Luis Diaz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Significant molar dental work, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand tooth enamel loss in individuals with certain types of cancer, including esophagogastric, colorectal, pancreatic, breast, head and neck, and non-small cell lung cancer, as well as in healthy individuals. Researchers will use an intra-oral camera to photograph participants' teeth and gather information through surveys. Those diagnosed with one of the specified cancers and interested in contributing to research on dental health in cancer patients are a good fit for this trial. As an unphased study, this trial allows participants to contribute to valuable research that could enhance dental care for cancer patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the intra-oral camera is safe for dental imaging?

Research has shown that intraoral cameras, such as the MouthWatch camera, are generally safe and don't cause negative effects. These cameras serve as helpful tools in dental offices, enabling both dentists and patients to better see and understand oral health. They capture clear images inside the mouth, aiding in the examination and diagnosis of dental issues without causing discomfort.

These cameras are commonly used and integrate well with dental imaging systems. No evidence indicates they cause harm, making them safe for use in clinical trials. Their main purpose is to capture images inside the mouth to detect signs of disease or changes in dental health. For those considering joining a trial using these cameras, research suggests they are a safe choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to assessing dental health in patients with various types of cancer, including esophagogastric cancer. Unlike traditional methods of cancer diagnosis and monitoring, which often rely on imaging techniques like endoscopies or biopsies, this trial uses intra-oral cameras to capture detailed images of patients' dental health. This non-invasive method is quick, easy, and could potentially provide new insights into the links between oral health and cancer progression. Additionally, collecting saliva samples might offer future possibilities for discovering biomarkers relevant to both dental and cancer health. Ultimately, this trial aims to uncover new connections between oral and systemic health, potentially leading to more holistic cancer care strategies.

What evidence suggests that the intraoral camera is effective for assessing dental health in cancer patients?

This trial uses intraoral cameras to assess dental health in different participant groups. Medical studies have shown promise for intraoral cameras in checking oral health issues. Research shows these cameras can clearly reveal conditions inside the mouth, such as oral secretions. For cancer patients, this proves especially helpful in spotting issues that might affect oral health. Studies also demonstrate that intraoral cameras aid cancer screenings by providing clear pictures of the mouth, helping to find potential problems early, which is crucial for timely treatment. Overall, the use of intraoral cameras is gaining recognition in both dental and cancer care for their ability to improve examination and detection. ^{1 2 3 6 7}

Who Is on the Research Team?

Steven Maron, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This study is for adults over 18 with esophagogastric cancer who can understand English or have translation services. They should be able to complete a survey and allow photos of their teeth, but those without teeth or major dental work on molars that affects enamel assessment cannot join.

Inclusion Criteria

Subject is willing and able to provide written informed consent

Patients must be able to understand English language or have access to adequate translation services

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

Exclusion Criteria

I have never had cancer (other than skin cancer) and am not being evaluated for reflux.

I don't have molars or have had significant dental work on them.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dental Imaging and Survey

Participants complete a survey and undergo dental imaging; optional saliva sample collection for esophagogastric cancer patients

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for the incidence of dental erosions over a year

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Intra-oral camera
• MouthWatch intra-oral camera
• Survey

Trial Overview The study aims to understand tooth enamel loss in people with various cancers including esophagogastric cancer. Participants will provide saliva samples, answer surveys about their oral health, and have pictures taken of their teeth using an intra-oral camera.

How Is the Trial Designed?

Group I: Patients diagnosed with esophagogastric cancer Experimental Treatment 3 Interventions

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

Group II: Patients diagnosed with colorectal, pancreatic, breast, head and neck, or non-small cell lung cancer Experimental Treatment 2 Interventions

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

Group III: Healthy volunteers who have not been diagnosed with cancer Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

The study evaluates the effectiveness and safety of different intraoral imaging methods, including D-speed film, E-speed film, and dental xeroradiographs, focusing on their diagnostic utility and radiation exposure.

Findings from laboratory studies and clinical trials provide insights into equipment reliability, patient acceptance, and cost-effectiveness, helping to guide recommendations for optimal imaging practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical recommendations for the use of D-speed film, E-speed film, and xeroradiography. Gratt, BM., White, SC., Halse, A.[2019]

Advancements in understanding the biology of esophageal cancer and surgical techniques have led to improved treatment outcomes for patients.

Neoadjuvant therapy, which is given before surgery, helps shrink tumors and increases the chances of successful surgical removal, resulting in better long-term survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Esophagus carcinoma: radical concepts]. Schilling, MK., Büchler, MW.[2008]

Neoadjuvant strategies, including chemotherapy and radiation, have been explored over the past 20 years to enhance surgical outcomes for patients with localized esophageal cancer, which has a low long-term survival rate of only one third.

The article critically reviews the effectiveness of multimodality approaches, suggesting that combining treatments may improve management and outcomes for this deadly disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined modality therapy of esophageal cancer. Juergens, RA., Forastiere, A.[2019]

In a study of 8,396 esophageal cancer patients, those receiving collaborative treatment across multiple institutions had a slightly lower adherence to guideline-recommended chemotherapy and radiation doses compared to those treated at a single institution.

Despite these differences, the rates of R0 resection and overall survival (90-day and 5-year) were similar between the two groups, suggesting that collaborative treatment is a viable option with manageable impacts on treatment quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a collaborative treatment model for trimodal management of esophageal cancer. Udelsman, BV., Ermer, T., Ely, S., et al.[2023]

The implementation of a regional video Upper-GI multidisciplinary team meeting (uMDTM) significantly increased the number of patients discussed and involved a resection center more frequently, leading to more curative surgical interventions for esophageal cancer.

Overall survival rates for patients with esophageal cancer improved from 24% to 30% over three years after the uMDTM was implemented, indicating a positive impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a regional video multidisciplinary team meeting is associated with an improved prognosis for patients with oesophageal cancer A mixed methods approach. Luijten, JCHBM., Haagsman, VC., Luyer, MDP., et al.[2022]

Esophageal cancer is the most rapidly increasing cancer in the Western world, with a poor overall survival rate despite advancements in treatment, highlighting the need for improved therapeutic strategies.

Neoadjuvant chemoradiation followed by surgery may enhance resectability and overall survival, but only patients with a major histopathological response benefit, indicating the importance of developing predictive molecular markers to tailor treatments effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular response prediction in multimodality treatment for adenocarcinoma of the esophagus and esophagogastric junction. Lurje, G., Lenz, HJ.[2018]

This study is the first systematic evaluation of intraoral cameras in dentistry, assessing five different models to provide insights on their performance.

Key factors such as image quality, ease of use, and the differences between analog and digital cameras were analyzed, highlighting the need for ongoing evaluations to guide practitioners in their purchasing decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic evaluation of intraoral cameras. Johnson, LA.[2015]

New technologies like intraoral cameras and digital imaging are enhancing the early detection of oral cancers, addressing limitations of traditional clinical examinations.

Oral cancers share risk factors with upper aero-digestive cancers, primarily tobacco and alcohol use, which are increasingly affecting women, highlighting the need for proactive detection strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Detection strategies and risk factors in oral cancers]. Scutariu, MM., Voroneanu, M., Ursache, M.[2011]

Intraoral photography is essential for the early detection and monitoring of potentially malignant oral lesions, which can help in timely triage and risk assessment, especially when patients have limited access to screening services.

The article provides practical recommendations for obtaining high-quality intraoral photographs using common devices like smartphones, which can enhance patient records and improve communication among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoral Photography Recommendations for Remote Risk Assessment and Monitoring of Oral Mucosal Lesions. Lin, I., Datta, M., Laronde, DM., et al.[2022]

In a survey of 1000 general dental practitioners in Great Britain, 36% reported using clinical photography, with a high response rate of 76%.

The main applications of clinical photography included patient instruction/motivation (72%), medico-legal documentation (68%), treatment planning (63%), and communication with laboratories (43%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of dental photography by general dental practitioners in Great Britain. Sharland, MR., Burke, FJ., McHugh, S., et al.[2018]

In a study of rural Chinese adults aged 40-67, nearly 17% were edentulous, and the average DMFT (decayed, missing, and filled teeth) score was 8.5, indicating significant oral health issues in this population.

Participants with poor oral health were found to be 1.59 times more likely to have esophageal dysplasia, suggesting a potential link between oral health and the risk of esophageal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using NHANES oral health examination protocols as part of an esophageal cancer screening study conducted in a high-risk region of China. Dye, BA., Wang, R., Lashley, R., et al.[2018]

The study assessed the caries status of 6,271 Polish children aged 5, 7, and 15 years, revealing that the nationwide caries prophylaxis program had very low participation rates, with only 3.8% of 5-year-olds and 48.3% of 7-year-olds involved in 2011.

Despite some participation, the percentage of children with sealed teeth was alarmingly low, indicating that the caries prevention efforts were insufficient and varied significantly across different regions of Poland.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polish public caries prophylaxis programme for children aged 5, 7 and 15 years, implemented in the year 2011. Jodkowska, E., Wierzbicka, M., Rusyan, E., et al.[2019]

In a study of 529 esophageal cancer patients, 39.2% of those who received preoperative dental care were diagnosed with slight periodontitis, and 29.7% with severe periodontitis, highlighting a significant prevalence of oral health issues in this population.

Patients who received preoperative dental examinations and care had a significantly lower incidence of severe pneumonia after esophagectomy compared to those who did not receive dental care, indicating that dental health management is crucial for improving postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal Cancer Patients Have a High Incidence of Severe Periodontitis and Preoperative Dental Care Reduces the Likelihood of Severe Pneumonia after Esophagectomy. Sato, Y., Motoyama, S., Takano, H., et al.[2017]

A pilot study involving 137 schoolchildren found that using an intraoral camera and telehealth technology for dental screenings produced results comparable to traditional visual methods, with agreement rates between 89% to 100%.

This telehealth approach could be particularly beneficial in underserved or remote areas, enabling accurate identification of oral health conditions and facilitating consultations between dental professionals and patients from a distance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental screenings using telehealth technology: a pilot study. Patterson, S., Botchway, C.[2006]

Citations

1. pubs.asha.org pubs.asha.org/doi/10.1044/2023_JSLHR-23-00375

Contribution of Wireless Wi-Fi Intraoral Cameras to the ... This preliminary retrospective study suggests that intraoral cameras can reveal the accumulated oropharyngeal secretions and postswallow pharyngolaryngeal ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38437030/

Contribution of Wireless Wi-Fi Intraoral Cameras to the ... This preliminary retrospective study suggests that intraoral cameras can reveal the accumulated oropharyngeal secretions and postswallow pharyngolaryngeal ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8570874/

Validity and Reliability of Intraoral Camera with Fluorescent ... This study aims to develop and evaluate the validity and reliability of the intraoral camera with the combination method of autofluorescence and LED white light

4. researchgate.net researchgate.net/publication/378712493_Contribution_of_Wireless_Wi-Fi_Intraoral_Cameras_to_the_Assessment_of_Swallowing_Safety_and_Efficiency

Contribution of Wireless Wi-Fi Intraoral Cameras to the ... Conclusions This preliminary retrospective study suggests that intraoral cameras can reveal the accumulated oropharyngeal secretions and postswallow ...

5. mouthwatch.com mouthwatch.com/resources/the-importance-of-intraoral-cameras-in-oral-cancer-screening?srsltid=AfmBOoq6VrO5MwSzQDN22Ra_JdQydVb5grw99C19ttknGRNKgmQ6yVkB

The Importance of Intraoral Cameras in Oral Cancer ... Intraoral cameras are an integral part of successful dental practices, proving a variety of benefits from case acceptance to claim support.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9445478/

A feasibility and acceptability study of using an intra-oral ... Of 39 patient participants, most strongly agreed or agreed that the use of an intra-oral camera by their dentists helped them to better understand oral cancer ...

7. mouthwatch.com mouthwatch.com/resources/the-importance-of-intraoral-cameras-in-oral-cancer-screening?srsltid=AfmBOorIHDDz1g4VZXydisia2bzq774ByS1p_Cus0kFhjcS6oPBJMvSi

The Importance of Intraoral Cameras in Oral Cancer ... Intraoral cameras are an integral part of successful dental practices, proving a variety of benefits from case acceptance to claim support.