Esophageal CancerNCT05480891
Transnasal Esophagoscopy (TNE) Esophageal Cancer Screening
An observational study of Esophageal Cancer, run by University of Illinois Chicago at 2 sites in United States.
Trial summary
This research study is being done for 2 reasons: 1) The investigators want to learn about the eating, smoking and drinking habits of adults, 18 years of age and older, in various Chicago communities, and 2) the investigators want to offer screening for participants whose smoking and drinking habits put them at risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Transnasal Esophagoscopy (TNE)
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Apr 2023to 19 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients will be recruited from UI Health Mile Square Community Health Centers, a Federally Qualified Health Center (FQHC). Mile Square has always been committed to serving Chicago's disenfranchised communities. Patients are predominantly minority; many of whom are at or below the Federal Poverty Level and have public insurance or are uninsured. The Mile Square system provides comprehensive primary care for children and adults. The system includes primary care clinics, as well school-based health centers and nurse-practice sites that provide health care for people with severe and persistent mental illness.
Who may be able to join
- Male and female patients 18 years of age or older
- Patients being seen at one of the UI Health Centers for an ear, nose, or throat related concern.
- Patients who have a history of both smoking and drinking.
- Patients must be willing to complete a study survey.
- Patients must understand the purpose and procedures of the study and be willing to participate.
- Patients who speak English.
- All adult men and women who meet the study criteria will be asked to participate in the study without regard to race, gender or socioeconomic status.
- For Part 2 of the study, inclusion criteria includes all patients 40 and over with a history or smoking and drinking as well as patients 18 years of age and older who present with dysphasia and/or pain when swallowing. Patients eligible for Part 2 of the study will be informed of the study, but they will not be consented during their clinic visit.
Who cannot join
- Male and Female patients under the age of 18.
- Patients who are not being seen at one of the UI Health Community Health
- Centers for an ear, nose or throat related concern.
- Patients who do not have a history of both drinking and smoking.
- Patients unwilling to complete the study survey.
- Women who are pregnant will be excluded from both Part 1 and Part 2 of the study.
Show all 11Show fewer
- Patients unable to understand the purpose and procedures of the study and/or who are not willing to participate.
- Patients who do not speak English.
- Excluded or Vulnerable Populations
- Minors will be excluded from the study because they are not at risk for the factors being studied in the research.
- Subjects who are not English speaking will be excluded due to the limited capacity of the primary investigators to obtain informed consent in this population.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mile Square Health Center-University of Illinois Hospital
Chicago, Illinois, 60608
University of Illinois
Chicago, Illinois, 60612
About this study
Official title: Repurposing Transnasal Esophagoscopy: Targeting Interventions for a Community That Has Been Targeted for Cancer Risk
This research study is being done for 2 reasons: 1) The investigators want to learn about the eating, smoking and drinking habits of adults, 18 years of age and older, in various Chicago communities, and 2) the investigators want to offer screening for participants whose smoking and drinking habits put them at risk for cancer.
Read the detailed description
There are longstanding disparities in healthcare outcomes in the United States. These differences often correlate from the effects of structural racism and how this factor has shaped healthcare in our society.
Esophageal cancer presents as one of two distinct histological cell types, adenocarcinoma and squamous cell carcinoma (SCC). The majority of White patients presenting with esophageal cancer are diagnosed with adenocarcinoma while Black and non-caucasian patients are more commonly diagnosed with squamous cell carcinoma. The detection and treatment of these two types of esophageal cancers vary.
Trans-nasal esophagoscopy (TNE) is used primarily to assess chronic acid reflux as well as Barrett's esophagus, both symptoms being associated with adenocarcinoma. The use of TNE for disease screening offers the opportunity for early diagnosis and treatment of esophageal adenocarcinoma. Currently there is no parallel method of screening and diagnosis for patients with the potential for squamous cell carcinoma (SCC).
In an effort to decrease the disease identification, diagnosis, and treatment gap between these populations, this study will evaluate the use of TNE as a screening tool for African-Americans and non-caucasian patients with high risk factors associated with the development of esophageal SCC.
All adult patients 18 years of age and older will be asked to participate in a survey at one of the UI Health community health centers. The survey will include questions about smoking and alcohol consumption habits, which have been shown to be specific risk factors associated with esophageal SCC. Additional information, such as the use of mentholated cigarettes and fortified wines will be surveyed as such products are selectively marketed in African American communities and may increase the prevalence of SCC in these communities. Following review of the survey results from the health centers, all patients presenting with a dysphasia or difficulty swallowing, and patients who are 40 years of age and older and who have been determined to be high risk for SCC based on their survey results, will be offered the opportunity to have a TNE screening for esophageal cancer. Data gathered as a result of the study will be shared with participating communities and with medical health providers in an effort to improve patient knowledge and access to quality healthcare.
There are longstanding, historical, and current disparities in healthcare outcomes in the United States.[1-4] While we often classify these differences as racial, they are more likely to correlate with the effects of systemic racism that manifest as societal determinants of health. Segregation, whether legally sanctioned or de facto, molds the composition of neighborhoods and significantly influences access to quality healthcare.
Esophageal cancer incidence, stage at diagnosis, and mortality is one disease process that highlights these discrepancies. This year, an estimated 19,260 adults, most of whom are expected to be males, will be diagnosed with esophageal cancer. The two major types of esophageal cancer are adenocarcinoma and squamous cell carcinoma. In the United States, esophageal cancer is more common in Caucasians than African Americans/non-Caucasians. In Caucasians the disease is frequently diagnosed as an adenocarcinoma, which implies the cancer arose from gland producing cells in the body. Squamous cell carcinoma, which originates from skin cells and mucosal linings in the body, is more common in the African American/non-Caucasian populations.
The five-year survival rate for esophageal cancer was reported to be five per cent four decades ago. Today the survival rate has improved to approximately twenty per cent. However, in 1970, the survival rate for White males was approximately four times that of Black/non-caucasian males, and in 2021, that ratio persists. Simply stated, Black and non-caucasian men are more likely to die from squamous cell cancer (SCCA) of the esophagus than any other demographic in the United States. The reason for the disparity in survival rates may be the result of a more proactive early screening process in the White population as symptoms arise. Adenocarcinoma, the more common form of esophageal cancer in the Caucasian population is frequently associated with Gastro-Esophageal Reflux Disease (GERD) or Barrett's esophagus. Early screenings and diagnosis of these two precursor causes of adenocarcinoma allows for early detection and treatment, thereby decreasing mortality. [8,9,19] Survival of esophageal cancer is associated with disease stage at diagnosis. Five-year survival is nearly 50% if the disease is diagnosed early and has not metastasized to lymph nodes or surrounding tissues or organs. Once the cancer has spread to lymph nodes, the average rate of survival is approximately 25%. If the cancer is not diagnosed until it has spread to other, more distant parts of the body, survival is estimated to be around 5%.
Trans-nasal esophagoscopy (TNE) is currently used primarily to assess chronic acid reflux as well as to screen for Barrett's esophagus. Clinicians have tended to employ this screening tool to look for changes that could lead to adenocarcinoma of the esophagus in response to symptoms. Caucasian males over age 50 are the primary target group for the current screening paradigm. Published reports and guidelines for the use of TNE as a screening tool for adenocarcinoma are readily available to the medical community. Patients, once diagnosed for GERD or Barrett's esophagus have annual visits with a gastroenterologist for sustained screening. Conversely, African-American/non-caucasian males who are considered at lower risk for Barrett's esophagus may not be referred for screening surveillance. The fact that African-American and non-caucasian males, particularly those with a history of alcohol and tobacco consumption, may be at increased risk for esophageal squamous cell carcinoma has not led to a specific screening protocol for this patient population. In fact, certain risks, such as mentholated cigarettes and fortified wines, which are selectively marketed in non-caucasian communities, may be a major factor in the increased prevalence and severity of SCC in these specific communities.
This study aims to evaluate the use of TNE as a screening tool for targeted populations with known risk factors for esophageal SCC. Specific symptoms are considered for the use of TNE for the diagnosis and treatment of esophageal adenocarcinoma, which is most prevalent in white males. This study aims to evaluate a more extensive use of TNE as a screening tool for at risk African American/non-Caucasian populations for the early diagnosis and treatment of esophageal squamous cell carcinoma.
- Conditions
- Esophageal Cancer
- Being tested
- Transnasal Esophagoscopy (TNE)
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal Esophagoscopy (TNE)Procedure or surgery
While seated in an upright position a topical numbing medicine will be sprayed in your nose and the back of your throat.
A thin, flexible tube less than ¼ inch in diameter, will be placed in one of your nostrils and advanced to the back of your throat. When the tube reaches the back of the throat you will be asked to drink sips of water to help move the tube into and down the esophagus as it is advanced. The tip of the tube has a small light and camera built in that allows the doctor to see the structures of the mouth and esophagus as the tube is advanced. Once the tube is in the esophagus, the physician will examine your esophagus for any abnormal changes.
Once the visual inspection is complete the tube will be gently removed through your nose. The procedure will take approximately 10-15 minutes of time.
What is being measured
The primary outcome is the main question the study is designed to answer.
Conduct a population survey of UI Health and Mile Square Community Center patients focusing on specific risk factors associated with esophageal squamous cell carcinoma (ESCC)
The researchers will collect data on the consumption of alcohol and tobacco as they are known risk factors for ESCC. The researchers will specifically assess consumption of fortified wines and mentholated cigarettes based on the targeted marketing of these products in identified communities. The researchers will also assess consumption of fresh fruits and vegetables and proportion of fat in dietary consumption to assess whether these conditions are associated with cancer risk.
Measured: Through study completion, an average of 2 years
Develop risk/screening criteria for esophageal squamous cell carcinoma in at risk populations
The researchers hope our data will serve to help create a risk stratification that can parallel current guidelines for screening patients for adenocarcinoma (which primarily affects Caucasian males). The researchers will compare results of trans-nasal esophagoscopy (TNE) exam and any biopsy specimens collected with the risk profile generated by survey results.
Measured: Through study completion, anticipating 2 years
community education
The design of this study includes partnership with the at-risk community to engage in education about the stated risk factors and promote preventive health and encourage participation in screenings.
Measured: Ongoing throughout the study, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start5 Apr 2023
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Why it stopped: Transnasal Esophagoscopy (TNE) scope is no longer manufactured so the study is unable to be continued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Cures Within Reach
- Responsible party
- Principal investigator, H Steven Sims, University of Illinois Chicago
- Investigators
- H. Steven Sims, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480891
- Sponsor's protocol ID
- 2022-0115
- Status last verified
- May 2025
- First submitted
- 20 Jul 2022
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repurposing Transnasal Esophagoscopy: Targeting Interventions for a Community That Has Been Targeted for Cancer Risk
- ClinicalTrials.gov ID
- NCT05480891
- Acronym / sponsor ID
- 2022-0115
- Conditions
- Esophageal Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Transnasal Esophagoscopy (TNE) scope is no longer manufactured so the study is unable to be continued.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Cures Within Reach
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being done for 2 reasons: 1) The investigators want to learn about the eating, smoking and drinking habits of adults, 18 years of age and older, in various Chicago communities, and 2) the investigators want to offer screening for participants whose smoking and drinking habits put them at risk for cancer.
Detailed description
There are longstanding disparities in healthcare outcomes in the United States. These differences often correlate from the effects of structural racism and how this factor has shaped healthcare in our society.
Esophageal cancer presents as one of two distinct histological cell types, adenocarcinoma and squamous cell carcinoma (SCC). The majority of White patients presenting with esophageal cancer are diagnosed with adenocarcinoma while Black and non-caucasian patients are more commonly diagnosed with squamous cell carcinoma. The detection and treatment of these two types of esophageal cancers vary.
Trans-nasal esophagoscopy (TNE) is used primarily to assess chronic acid reflux as well as Barrett's esophagus, both symptoms being associated with adenocarcinoma. The use of TNE for disease screening offers the opportunity for early diagnosis and treatment of esophageal adenocarcinoma. Currently there is no parallel method of screening and diagnosis for patients with the potential for squamous cell carcinoma (SCC).
In an effort to decrease the disease identification, diagnosis, and treatment gap between these populations, this study will evaluate the use of TNE as a screening tool for African-Americans and non-caucasian patients with high risk factors associated with the development of esophageal SCC.
All adult patients 18 years of age and older will be asked to participate in a survey at one of the UI Health community health centers. The survey will include questions about smoking and alcohol consumption habits, which have been shown to be specific risk factors associated with esophageal SCC. Additional information, such as the use of mentholated cigarettes and fortified wines will be surveyed as such products are selectively marketed in African American communities and may increase the prevalence of SCC in these communities. Following review of the survey results from the health centers, all patients presenting with a dysphasia or difficulty swallowing, and patients who are 40 years of age and older and who have been determined to be high risk for SCC based on their survey results, will be offered the opportunity to have a TNE screening for esophageal cancer. Data gathered as a result of the study will be shared with participating communities and with medical health providers in an effort to improve patient knowledge and access to quality healthcare.
There are longstanding, historical, and current disparities in healthcare outcomes in the United States.[1-4] While we often classify these differences as racial, they are more likely to correlate with the effects of systemic racism that manifest as societal determinants of health. Segregation, whether legally sanctioned or de facto, molds the composition of neighborhoods and significantly influences access to quality healthcare.
Esophageal cancer incidence, stage at diagnosis, and mortality is one disease process that highlights these discrepancies. This year, an estimated 19,260 adults, most of whom are expected to be males, will be diagnosed with esophageal cancer. The two major types of esophageal cancer are adenocarcinoma and squamous cell carcinoma. In the United States, esophageal cancer is more common in Caucasians than African Americans/non-Caucasians. In Caucasians the disease is frequently diagnosed as an adenocarcinoma, which implies the cancer arose from gland producing cells in the body. Squamous cell carcinoma, which originates from skin cells and mucosal linings in the body, is more common in the African American/non-Caucasian populations.
The five-year survival rate for esophageal cancer was reported to be five per cent four decades ago. Today the survival rate has improved to approximately twenty per cent. However, in 1970, the survival rate for White males was approximately four times that of Black/non-caucasian males, and in 2021, that ratio persists. Simply stated, Black and non-caucasian men are more likely to die from squamous cell cancer (SCCA) of the esophagus than any other demographic in the United States. The reason for the disparity in survival rates may be the result of a more proactive early screening process in the White population as symptoms arise. Adenocarcinoma, the more common form of esophageal cancer in the Caucasian population is frequently associated with Gastro-Esophageal Reflux Disease (GERD) or Barrett's esophagus. Early screenings and diagnosis of these two precursor causes of adenocarcinoma allows for early detection and treatment, thereby decreasing mortality. [8,9,19] Survival of esophageal cancer is associated with disease stage at diagnosis. Five-year survival is nearly 50% if the disease is diagnosed early and has not metastasized to lymph nodes or surrounding tissues or organs. Once the cancer has spread to lymph nodes, the average rate of survival is approximately 25%. If the cancer is not diagnosed until it has spread to other, more distant parts of the body, survival is estimated to be around 5%.
Trans-nasal esophagoscopy (TNE) is currently used primarily to assess chronic acid reflux as well as to screen for Barrett's esophagus. Clinicians have tended to employ this screening tool to look for changes that could lead to adenocarcinoma of the esophagus in response to symptoms. Caucasian males over age 50 are the primary target group for the current screening paradigm. Published reports and guidelines for the use of TNE as a screening tool for adenocarcinoma are readily available to the medical community. Patients, once diagnosed for GERD or Barrett's esophagus have annual visits with a gastroenterologist for sustained screening. Conversely, African-American/non-caucasian males who are considered at lower risk for Barrett's esophagus may not be referred for screening surveillance. The fact that African-American and non-caucasian males, particularly those with a history of alcohol and tobacco consumption, may be at increased risk for esophageal squamous cell carcinoma has not led to a specific screening protocol for this patient population. In fact, certain risks, such as mentholated cigarettes and fortified wines, which are selectively marketed in non-caucasian communities, may be a major factor in the increased prevalence and severity of SCC in these specific communities.
This study aims to evaluate the use of TNE as a screening tool for targeted populations with known risk factors for esophageal SCC. Specific symptoms are considered for the use of TNE for the diagnosis and treatment of esophageal adenocarcinoma, which is most prevalent in white males. This study aims to evaluate a more extensive use of TNE as a screening tool for at risk African American/non-Caucasian populations for the early diagnosis and treatment of esophageal squamous cell carcinoma.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will be recruited from UI Health Mile Square Community Health Centers, a Federally Qualified Health Center (FQHC). Mile Square has always been committed to serving Chicago's disenfranchised communities. Patients are predominantly minority; many of whom are at or below the Federal Poverty Level and have public insurance or are uninsured. The Mile Square system provides comprehensive primary care for children and adults. The system includes primary care clinics, as well school-based health centers and nurse-practice sites that provide health care for people with severe and persistent mental illness.
Key inclusion criteria (8 listed)
- Male and female patients 18 years of age or older
- Patients being seen at one of the UI Health Centers for an ear, nose, or throat related concern.
- Patients who have a history of both smoking and drinking.
- Patients must be willing to complete a study survey.
- Patients must understand the purpose and procedures of the study and be willing to participate.
Key exclusion criteria (11 listed)
- Male and Female patients under the age of 18.
- Patients who are not being seen at one of the UI Health Community Health
- Centers for an ear, nose or throat related concern.
- Patients who do not have a history of both drinking and smoking.
- Patients unwilling to complete the study survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transnasal Esophagoscopy (TNE)While seated in an upright position a topical numbing medicine will be sprayed in your nose and the back of your throat. A thin, flexible tube less than ¼ inch in diameter, will be placed in one of your nostrils and advanced to the back of your throat. When the tube reaches the back of the throat you will be asked to drink sips of water to help move the tube into and down the esophagus as it is advanced. The tip of the tube has a small light and camera built in that allows the doctor to see the structures of the mouth and esophagus as the tube is advanced. Once the tube is in the esophagus, the physician will examine your esophagus for any abnormal changes. Once the visual inspection is complete the tube will be gently removed through your nose. The procedure will take approximately 10-15 minutes of time. | Procedure or surgery | – |
Primary outcome
Conduct a population survey of UI Health and Mile Square Community Center patients focusing on specific risk factors associated with esophageal squamous cell carcinoma (ESCC)
Time frame: Through study completion, an average of 2 years
The researchers will collect data on the consumption of alcohol and tobacco as they are known risk factors for ESCC. The researchers will specifically assess consumption of fortified wines and mentholated cigarettes based on the targeted marketing of these products in identified communities. The researchers will also assess consumption of fresh fruits and vegetables and proportion of fat in dietary consumption to assess whether these conditions are associated with cancer risk.
Develop risk/screening criteria for esophageal squamous cell carcinoma in at risk populations
Time frame: Through study completion, anticipating 2 years
The researchers hope our data will serve to help create a risk stratification that can parallel current guidelines for screening patients for adenocarcinoma (which primarily affects Caucasian males). The researchers will compare results of trans-nasal esophagoscopy (TNE) exam and any biopsy specimens collected with the risk profile generated by survey results.
community education
Time frame: Ongoing throughout the study, approximately 2 years
The design of this study includes partnership with the at-risk community to engage in education about the stated risk factors and promote preventive health and encourage participation in screenings.
Results and safety
The study was stopped early (reason given: Transnasal Esophagoscopy (TNE) scope is no longer manufactured so the study is unable to be continued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Steven Sims, MD principal investigator
University of Illinois Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by University of Illinois Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Transnasal Esophagoscopy (TNE) scope is no longer manufactured so the study is unable to be continued.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conduct a population survey of UI Health and Mile Square Community Center patients focusing on specific risk factors associated with esophageal squamous cell carcinoma (ESCC) (time frame: Through study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.