Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05480891 |
| Other study ID # |
2022-0115 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 5, 2023 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
May 2023 |
| Source |
University of Illinois at Chicago |
| Contact |
H. Steven Sims, MD |
| Phone |
312-996-6582 |
| Email |
hssims[@]uic.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 for cancer.
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.
