Esophageal Cancer Clinical Trial

Biomarkers of Airway Disease, Barrett’s and Underdiagnosed Reflux Noninvasively (BADBURN)

Summary

A majority of Fire Department of New York (FDNY) World Trade Center (WTC) exposed rescue and recovery workers developed gastroesophageal reflux disease (GERD), a risk factor for Barrett's Esophagus (BE) and subsequent esophageal cancer. There is diminished health-related quality of life and productivity associated with aerodigestive diseases such as GERD and BE.

This proposal will leverage the longitudinally phenotyped WTC exposed cohort, validate biomarkers of WTC-aerodigestive disease, and develop novel, noninvasive disease phenotyping of premalignant diseases such as BE, and identify potential targeted therapeutics to improve care.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age 37-90
FDNY rescue and recovery worker.
Male*
Documented WTC exposure.
Consented/Enrolled in the FDNY WTC Health Program
Subjects are willing and able to consent for themselves to study enrollment
Subjects are willing and able to participate in study procedures
Are able to perform their activities of daily living independently
Are either light duty or retired FDNY Firefighters
Spirometry available within the last 24 months, and at a post-9/11 visit.
Have means to accommodate transportation to/from in-person visit Are able to attend a single visit at the CTSI (462 1st Avenue, C & D 4th Floor)
Pre-9/11 spirometry with FEV1%predicted ≥LLN and if not available 1st -post 9/11 spirometry with an FEV1 >80% predicted.
Exposure at the WTC-site within 2 weeks of the 9/11/2001
Entered WTC-HP before the site closure on 7/24/2002.
Serum from their first post 9/11 WTC-HP visit is available in the FDNY WTC biorepository and may be assayed
Are not currently being treated for malignancy
Subjects will either need to be defined as having WTC-AHR, WTC-GERD, WTC-BE or be designated controls as per the following additional inclusion criteria are specific to the WTC-aerodigestive disease that the subjects have
AHR--A positive methacholine (PC20<16) and/or positive bronchodilator response (ATS/ERS guidelines: improvement of FEV1 by 12% and at least 200mL) at least once post-9/11.[95, 96]No recorded positive AHR testing prior to 9/11

GERD Inclusion Criteria

Erosive esophagitis LA grade C or D (as described on endoscopy), OR
Stricture or Barrett's esophagus on endoscopy, OR
Esophageal acid exposure time >6% on a pH or pH impedance study

19. BE Inclusion Criteria

Columnar epithelium lining ≥1 cm of the distal esophagus. AND
Histologic examination of biopsy specimens from that columnar epithelium must reveal intestinal metaplasia characterized with goblet cells.

Exclusion Criteria:

Unwilling to complete an informed consent.
Not enrolled in the WTC-HP
Do not meet eligibility criteria for AIM 1 or did not have serum available in the biorepository from the first post 9/11 WTC-HP visit.
Have pre-existing and documented conditions or concurrent diagnoses, including (and not necessarily limited to) active cancer, severe heart disease, significant cognitive impairment, eating disorders, significant psychiatric illness, end-stage COPD, severe pulmonary hypertension, or organ transplant.
High dose steroid (>20mg prednisone or equivalent) or other hormonal treatments/chemotherapy use in the last month, including testosterone supplementation.
Life-expectancy < 6 months
Female*

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

200

Study ID:

NCT05216133

Recruitment Status:

Not yet recruiting

Sponsor:

NYU Langone Health

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There is 1 Location for this study

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NYU Clinical & Translational Science Institute Clinical Research Center (CTSI CRC)
New York New York, 10016, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

200

Study ID:

NCT05216133

Recruitment Status:

Not yet recruiting

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

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