Transnasal Esophagoscopy (TNE) Esophageal Cancer Screening

NCT05480891 | Terminated

• 1 other identifier: 2022-0115
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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 for cancer.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Ongoing throughout the study, approximately 2 years

Interventions

Transnasal Esophagoscopy (TNE) PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Cures Within Reach: collaborator

Study Sites (2)

Mile Square Health Center-University of Illinois Hospital

Chicago, Illinois, 60608, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• H. Steven Sims, MD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Francis L. Lederer Professor, Otolaryngology - Head and Neck Surgery Director, The Chicago Institute for Voice Care (CIVC)

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 29, 2022
• Study Start: April 5, 2023
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)