Trial Title:
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
NCT ID:
NCT06071845
Condition:
Barrett Esophagus
Barretts Esophagus With Dysplasia
Barrett's Esophagus Without Dysplasia
Esophageal Adenocarcinoma
Conditions: Official terms:
Barrett Esophagus
Hyperplasia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective multi-center case control study
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Cytosponge Procedure
Description:
Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to
administer and retrieve the Cytosponge device.
Arm group label:
Known or Suspected Barrett's Esophagus (Case Arm)
Arm group label:
No Known Barrett's Esophagus (Control Arm)
Intervention type:
Diagnostic Test
Intervention name:
Endoscopic Assessment
Description:
Participants will undergo a diagnostic clinically indicated sedated endoscopy with
standard endoscopic equipment.
Arm group label:
Known or Suspected Barrett's Esophagus (Case Arm)
Arm group label:
No Known Barrett's Esophagus (Control Arm)
Summary:
This clinical trial evaluates the use of cytosponge, a minimally invasive collection
device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy.
Non-endoscopic swallowable encapsulate sponge cell collection devices combined with
markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed
alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus
test (OGE) test uses esophageal cytology specimens collected with a minimally invasive,
non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that
indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple
and cost effective screening method that may lower barriers to widespread adoption of BE
screening in at risk patients, resulting in increased and earlier detection of BE/EAC.
Detailed description:
PRIMARY OBJECTIVES:
I. Measure Deoxyribonucleic acid (DNA) yield from esophageal cytology samples collected
with the Cytosponge device.
II. Evaluate the methylated DNA markers (MDM) levels and accuracy of the Oncoguard
Esophagus test (OGE test) for the detection of methylated DNA markers in Cytosponge
collected esophageal cytology samples.
SECONDARY OBJECTIVES:
I. Assess the tolerability of the Cytosponge device using a tolerability questionnaire
II. Evaluate presence of any trauma to the esophagus from the passage of the Cytosponge
device using the endoscopic injury score.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients with known or suspected Barrett's Esophagus undergo a biopsy and sample
collection with the cytosponge followed by standard of care endoscopy and complete
surveys while on study.
ARM II: Patients without known or suspected Barrett's Esophagus undergo a biopsy and
sample collection with the cytosponge followed by standard of care endoscopy and complete
surveys while on study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Subjects with known or suspected Barrett's esophagus (BE) (cases)
- Patients between the ages of 18-90.
- Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected
BE in medical record.
- Histology showing evidence of intestinal metaplasia with or without presence of
dysplasia or suspected BE in medical record.
- Undergoing clinically indicated endoscopy.
- Subjects without known history of BE (controls)
- Undergoing clinically indicated diagnostic endoscopy
Exclusion Criteria:
- For subjects with or without known evidence of BE (on history or review of medical
records)
- Pregnant or lactating females.
- Patients who are unable to consent.
- Patients with current history of uninvestigated dysphagia.
- History of eosinophilic esophagitis, achalasia.
- Patients on oral anticoagulation including Coumadin, Warfarin.
- Patients on antiplatelet agents including Clopidogrel, unless discontinued for
three to five days prior to the Cytosponge procedure.
- Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa
inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for
three to five days prior to the Cytosponge procedure.
- Patients with history of known esophageal or gastric varices or cirrhosis.
- Patients with history of surgical esophageal resection for esophageal
carcinoma.
- Patients with congenital or acquired bleeding diatheses.
- Patients with a history of esophageal squamous dysplasia.
- Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary,
stomach, or duodenum) within 5 years prior to study enrollment.
- Patient has received chemotherapy class drugs or radiation to treat mediastinal
or esophageal cancer.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Prasad Iyer, M.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Herbert C. Wolfsen, M.D.
Email:
Principal Investigator
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justeena Jojo
Phone:
312-926-4977
Email:
justeena.jojo@northwestern.edu
Investigator:
Last name:
Srinadh Komanduri, M.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Prasad G. Iyer, M.D.
Email:
Principal Investigator
Facility:
Name:
Long Island Jewish Medical Center | Northwell Health
Address:
City:
New Hyde Park
Zip:
11040
Country:
United States
Status:
Recruiting
Contact:
Last name:
Molly Stewart
Phone:
718-470-4667
Email:
mstewart8@northwell.edu
Investigator:
Last name:
Arvind Trindade, MD
Email:
Principal Investigator
Start date:
October 16, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06071845
https://www.mayo.edu/research/clinical-trials
