Back to resultsAssessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples (SOS4C)
Primary Purpose
Barrett Esophagus, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cytosponge Procedure
Endoscopic Assessment
Sponsored by
About this trial
This is an interventional screening trial for Barrett Esophagus
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.
Sites / Locations
- Mayo Clinic in Florida
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Known or Suspected Barrett's Esophagus (Case Arm)
No Known Barrett's Esophagus (Control Arm)
Arm Description
Investigators will follow Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.c. After the sponge is retrieved, it will then be placed in a vial of cell preservative solution (PN DD-13631, Exact Sciences, Madison, WI) and shipped to the Exact Sciences laboratory for further processing and subsequent analysis.
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
Outcomes
Primary Outcome Measures
DNA yield from esophageal cytology samples collected with the Cytosponge device
DNA concentration from samples collected with the Cytosponge device will be compared with DNA concentration previously observed from samples collected with the EsophaCap device on another study. The DNA concentration range for EsophaCap collected specimens ranged from 0.4 to 285ng/uL.
Accuracy of the Oncoguard Esophagus (OGE) test
Methylated DNA marker (MDM) levels and accuracy (sensitivity and specificity) will be evaluated to determine the accuracy of the OGE test using Cytosponge-collected esophageal samples. Accuracy will be established using upper endoscopy with pathology confirmed histology as the criterion standard for the diagnosis of Barrett's Esophagus (BE). The recently established algorithm for defining the OGE test as positive or negative (from EsophaCap samples collected from another study) will be utilized to adjudicate the Cytosponge samples as positive or negative. Accuracy of the OGE test for the Cytosponge device will be assessed in relation to the estimates and confidence intervals previously observed.
Secondary Outcome Measures
Tolerability of the Cytosponge device
Tolerability will be assessed with a 6-question Tolerability Questionnaire using a 0-10 pain scale where 0 is none and 10 is severe (0 is good and 10 is not good).
Trauma to the esophagus from the passage of the Cytosponge device
Presence of any trauma from the passage of the sponge will be assessed and recorded photographically during the sedated endoscopy. This will be defined as: No evidence of trauma; Superficial mucosal abrasion without bleeding; Superficial mucosal tear abrasion with minimal oozing similar to that from biopsy; Deep mucosal abrasion without bleeding; Deep mucosal abrasion with greater than minimal oozing; or Bleeding requiring endoscopic therapy or perforation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06071845
Brief Title
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
Acronym
SOS4C
Official Title
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus With and Without Dysplasia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus, Barretts Esophagus With Dysplasia, Barrett's Esophagus Without Dysplasia, Esophageal Adenocarcinoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective multi-center case control study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Known or Suspected Barrett's Esophagus (Case Arm)
Arm Type
Experimental
Arm Description
Investigators will follow Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.c. After the sponge is retrieved, it will then be placed in a vial of cell preservative solution (PN DD-13631, Exact Sciences, Madison, WI) and shipped to the Exact Sciences laboratory for further processing and subsequent analysis.
Arm Title
No Known Barrett's Esophagus (Control Arm)
Arm Type
Active Comparator
Arm Description
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
Intervention Type
Device
Intervention Name(s)
Cytosponge Procedure
Intervention Description
Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.
Intervention Type
Diagnostic Test
Intervention Name(s)
Endoscopic Assessment
Intervention Description
Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.
Primary Outcome Measure Information:
Title
DNA yield from esophageal cytology samples collected with the Cytosponge device
Description
DNA concentration from samples collected with the Cytosponge device will be compared with DNA concentration previously observed from samples collected with the EsophaCap device on another study. The DNA concentration range for EsophaCap collected specimens ranged from 0.4 to 285ng/uL.
Time Frame
12 months
Title
Accuracy of the Oncoguard Esophagus (OGE) test
Description
Methylated DNA marker (MDM) levels and accuracy (sensitivity and specificity) will be evaluated to determine the accuracy of the OGE test using Cytosponge-collected esophageal samples. Accuracy will be established using upper endoscopy with pathology confirmed histology as the criterion standard for the diagnosis of Barrett's Esophagus (BE). The recently established algorithm for defining the OGE test as positive or negative (from EsophaCap samples collected from another study) will be utilized to adjudicate the Cytosponge samples as positive or negative. Accuracy of the OGE test for the Cytosponge device will be assessed in relation to the estimates and confidence intervals previously observed.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Tolerability of the Cytosponge device
Description
Tolerability will be assessed with a 6-question Tolerability Questionnaire using a 0-10 pain scale where 0 is none and 10 is severe (0 is good and 10 is not good).
Time Frame
7 days
Title
Trauma to the esophagus from the passage of the Cytosponge device
Description
Presence of any trauma from the passage of the sponge will be assessed and recorded photographically during the sedated endoscopy. This will be defined as: No evidence of trauma; Superficial mucosal abrasion without bleeding; Superficial mucosal tear abrasion with minimal oozing similar to that from biopsy; Deep mucosal abrasion without bleeding; Deep mucosal abrasion with greater than minimal oozing; or Bleeding requiring endoscopic therapy or perforation.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasad G. Iyer, M.D.
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Herbert C. Wolfsen, M.D.
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Prasad G. Iyer, M.D.
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples
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