Cytosponge Adequacy Study Evaluation II

Assessment of a Minimally Invasive Esophageal Cytology Collection System in Patients With Barrett's Esophagus or GERD Symptoms

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02395471

Acronym

CASEII

Enrollment

191

Registered

2015-03-23

Start date

2015-08-31

Completion date

2018-06-01

Last updated

2019-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's Esophagus, GERD

Brief summary

This study will assess the Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett's Esophagus or GERD Symptoms.

Detailed description

This is a cross-sectional study of subjects with Barrett's esophagus (BE) to assess the utility of the Cytosponge device as a non-endoscopic method for collecting surface cells from the esophagus. This study will enroll 2 groups of subjects: 1) Subjects presenting for routine endoscopic BE surveillance examinations (n=120), and 2) Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE (n=55). After informed consent, and on the same day as the endoscopic procedure, the subject will undergo administration of the Cytosponge device and complete a questionnaire. The subject will then undergo routine upper endoscopy, with assessment of BE (where applicable), and biopsy per accepted surveillance or screening recommendations. The Cytosponge will be placed in fixative and shipped to an accredited pathology laboratory for embedding in paraffin and hematoxylin and eosin (H&E) staining to assess the adequacy of the specimen. Further evaluation of the specimen may be performed using trefoil factor 3 (TFF3). If the Cytosponge tissue specimen is inadequate, the subject will be recalled for a repeat sponge procedure (not endoscopy) 30 days later. Routine care tissue biopsies will undergo standard processing and H&E staining at the home institution, with assessment by expert gastrointestinal pathologists. Subjects will be contacted via phone 7 days (+/- 2 days) after Cytosponge administration to complete additional questionnaires and assess adverse events.

Interventions

DEVICECytosponge™ Cell Collection Device

Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Male or female subjects, age 18 and above. 2. Able to read, comprehend, and complete the consent form. 3. Clinically fit for an endoscopy. 4. a) Previous confirmed diagnosis of Barrett's esophagus with intestinal metaplasia, and Prague classification of at least one circumferential centimeter of BE or a total BE segment length of at least 3 centimeters (C1+ or CXM3+) (BE arm) . OR b) If the subject does not have documented Prague Classification prior to screening, but the PI is convinced that the subject will meet the inclusion criteria based on previous documentation (for instance, mention of long-segment BE, they may enroll the subject in the study at their discretion. The study upper endoscopy must confirm that the subject has C1+ or CXM3+ (BE arm). If (C1+ or CXM3+) is not observed at the time of study endoscopy, the subject may still be enrolled but not included in the data analysis with the BE cohort. The data may be analyzed in a separate cohort. OR c) Self-reported heartburn or regurgitation on at least a monthly basis for at least 6 months (GERD arm).

Exclusion criteria

1. Individuals with a diagnosis of an oropharynx, esophageal or gastro-esophageal tumor, or symptoms of dysphagia. 2. Any history of esophageal varices, stricture, or prior dilation of the esophagus. 3. Current use of anti-thrombotics (anti-coagulants and anti-platelet drugs) that cannot be safely discontinued for the appropriate drug-specific interval in the peri-administration period. Depending on the particular agent or reason for the anti-thrombotic therapy, it may not be necessary to discontinue anti-thrombotic agents. There could be circumstances where the drug may not need to be discontinued if the risk of bleeding is considered negligible (e.g. daily aspirin therapy). Physicians should use their clinical judgement and should consult guidelines such as those provided by the ASGE. 4. Known bleeding disorder. 5. Individuals who have had a myocardial infarction or any cardiac event \< 6 months prior to enrollment. 6. Individuals who have had a cerebrovascular event \< 6 months prior to enrollment in which swallowing was affected. 7. Prior ablative or resection therapy of the esophagus including radiofrequency ablation (RFA), photodynamic therapy (PDT), spray cryotherapy, endoscopic mucosal resection, and other ablation therapies. 8. Any history of esophageal surgery, except for uncomplicated fundoplication. 9. Do not need upper endoscopy as part of patient management. 10. Pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Procedure Preference and Acceptability Questionnaire and Visual Analog Scale	Immediately post procedure up to 7 days +/- 3 days	The first primary objective of the study was to assess the acceptability of a novel, minimally invasive esophageal mucosal sampling technique, the Cytosponge™, in subjects undergoing surveillance of BE who have had at least a C1 or M3 segment confirmed, and 2) in subjects with GERD undergoing screening for BE. This includes measures of acceptability as demonstrated on the Impact of Event Scale, a Visual Analog Scale for Pain, and the subject's willingness to undergo repeat Cytosponge™ administration if it were offered to him/her. The Visual Analog Scale is measured from 0-100 scale for pain, 0 representing no pain and 100 representing the highest level of pain.
Number of Participants With Adequate Cytosponge™ Sample	Immediately post procedure up to 7 days +/- 3 days	To assess the adequacy of cytology samples obtained by Cytosponge in this population after 1 sampling, and after 2 samplings if first sample inadequate.

Secondary

Measure	Time frame	Description
Cytosponge™ Operating Characteristics as a Function of Baseline Histology	Immediately post procedure up to 7 days +/- 3 days	The third secondary objective was to assess the operating characteristics of Cytosponge™ as a function of baseline histology. At the outset of this study, no data was available regarding the accuracy of TFF3 in samples collected by Cytosponge™ in subjects with BE and more advanced disease (low-grade dysplasia and high-grade dysplasia). These subjects are at greatest risk for progression to cancer. We planned to collect pilot data on operating characteristics of the assay by degree of baseline dysplasia. We hypothesized that TFF3 would perform with similar operating characteristics in this group compared to non-dysplastic BE.
Operating Characteristics	Immediately post procedure up to 7 days +/- 3 days	The operating characteristics of this technique against a gold standard of upper endoscopy with biopsies for endoscopic surveillance in subjects with BE who demonstrate an adequate sample on Cytosponge assessment.
Ongoing Safety Measures	Immediately post procedure up to 7 days +/- 3 days	To collect and analyze ongoing safety measures of Cytosponge use in the target population.
Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy	Immediately post procedure up to 7 days +/- 3 days	The fourth secondary objective was to assess the degree of mucosal abrasion following Cytosponge™ administration, using a standardized scale. The incidence is presented in the data below for abrasion, bleeding and perforation observed during Endoscopy.
Cytosponge™ Operating Characteristics vs Worst Histology Ever	Immediately post procedure up to 7 days +/- 3 days	The second secondary objective was to assess the operating characteristics of Cytosponge™ against the worst ever histology documented in the subject.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Patient Wth Barrett's Subjects presenting for routine endoscopic BE surveillance examinations Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.	129
Patients With GERD Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE Cytosponge™ Cell Collection Device: Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.	62
Total	191

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Failure to swollow sponge twice	1	0
Overall Study	Lost to Follow-up	2	0
Overall Study	Patient did not return for procedure	0	1
Overall Study	Physician Decision	1	0
Overall Study	Protocol Violation	0	1
Overall Study	Subject not eligible	1	0
Overall Study	Withdrawal by Subject	2	1

Baseline characteristics

Characteristic	Patients With GERD	Total	Patient Wth Barrett's
Age, Continuous	54.2 years STANDARD_DEVIATION 15.1	60.8 years STANDARD_DEVIATION 12.9	64 years STANDARD_DEVIATION 10.4
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	6 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants	184 Participants	127 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Asian	2 Participants	3 Participants	1 Participants
Race/Ethnicity, Customized Black or African American	5 Participants	5 Participants	0 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Other	2 Participants	3 Participants	1 Participants
Race/Ethnicity, Customized White	52 Participants	179 Participants	127 Participants
Sex: Female, Male Female	39 Participants	75 Participants	36 Participants
Sex: Female, Male Male	23 Participants	116 Participants	93 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 129	0 / 62
other Total, other adverse events	8 / 129	6 / 62
serious Total, serious adverse events	2 / 129	0 / 62

Outcome results

Primary

Number of Participants With Adequate Cytosponge™ Sample

To assess the adequacy of cytology samples obtained by Cytosponge in this population after 1 sampling, and after 2 samplings if first sample inadequate.