A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus
NCT ID: NCT02560623
Last Updated: 2022-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
242 participants
INTERVENTIONAL
2015-10-15
2021-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Phase 1: Sponge on a String 25 mm 10 pores/inch
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Biopsy
Undergo biopsy
Biospecimen Collection
Undergo collection of blood sample
Endoscopic Procedure
Undergo endoscopy
Swallowable Sponge Cell Sampling Device
Undergo swallowable sponge cell sampling assessment
Phase 1: Sponge on a String 25 mm 20 pores/inch
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Biopsy
Undergo biopsy
Biospecimen Collection
Undergo collection of blood sample
Endoscopic Procedure
Undergo endoscopy
Swallowable Sponge Cell Sampling Device
Undergo swallowable sponge cell sampling assessment
Phase 2: Cases - Barrett's Esophagus
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Biopsy
Undergo biopsy
Endoscopic Procedure
Undergo endoscopy
Swallowable Sponge Cell Sampling Device
Undergo swallowable sponge cell sampling assessment
Phase 2: Controls - No Barrett's Esophagus
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Biopsy
Undergo biopsy
Endoscopic Procedure
Undergo endoscopy
Swallowable Sponge Cell Sampling Device
Undergo swallowable sponge cell sampling assessment
Interventions
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Biopsy
Undergo biopsy
Biospecimen Collection
Undergo collection of blood sample
Endoscopic Procedure
Undergo endoscopy
Swallowable Sponge Cell Sampling Device
Undergo swallowable sponge cell sampling assessment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a BE segment ≥ 1cm in maximal extent endoscopically.
* Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.
* Undergoing clinically indicated endoscopy. Subjects without known evidence of BE - Undergoing clinically indicated diagnostic endoscopy
Exclusion Criteria
* Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded.
* Patients with history of esophageal resection for esophageal carcinoma. 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 eosinophilic esophagitis, achalasia or uninvestigated dysphagia.
* Patients on oral anticoagulation including Coumadin, Warfarin.
* Patients on antiplatelet agents including Clopidogrel, unless discontinued for 3 days prior to the sponge procedure.
* Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 3 days prior to the sponge procedure.
* Patients with history of known varices or cirrhosis.
* Patients with history of 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.
18 Years
90 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Exact Sciences Corporation
INDUSTRY
Mayo Clinic
OTHER
Responsible Party
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Prasad G. Iyer
Principal Investigator
Principal Investigators
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Prasad G Iyer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic Health System - Mankato
Mankato, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Northwell Health
Manhasset, New York, United States
Baylor University Medical Center
Dallas, Texas, United States
Countries
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References
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Iyer PG, Slettedahl SW, Mahoney DW, Giakoumopoulos M, Olson MC, Krockenberger M, Taylor WR, Foote P, Berger C, Leggett C, Wu TT, Antpack E, Falk GW, Ginsberg GG, Abrams JA, Lightdale CJ, Ramirez F, Kahn A, Wolfsen H, Konda V, Trindade AJ, Kisiel JB. Algorithm Training and Testing for a Nonendoscopic Barrett's Esophagus Detection Test in Prospective Multicenter Cohorts. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1596-1604.e4. doi: 10.1016/j.cgh.2024.03.003. Epub 2024 Mar 19.
Iyer PG, Taylor WR, Slettedahl SW, Lansing RL, Hemminger LL, Cayer FK, Mahoney DW, Giakoumopoulos M, Allawi HT, Wu TT, Wang KK, Wolfsen HC, Antpack E, Kisiel JB. Validation of a methylated DNA marker panel for the nonendoscopic detection of Barrett's esophagus in a multisite case-control study. Gastrointest Endosc. 2021 Sep;94(3):498-505. doi: 10.1016/j.gie.2021.03.937. Epub 2021 Apr 20.
Iyer PG, Taylor WR, Johnson ML, Lansing RL, Maixner KA, Yab TC, Simonson JA, Devens ME, Slettedahl SW, Mahoney DW, Berger CK, Foote PH, Smyrk TC, Wang KK, Wolfsen HC, Ahlquist DA. Highly Discriminant Methylated DNA Markers for the Non-endoscopic Detection of Barrett's Esophagus. Am J Gastroenterol. 2018 Aug;113(8):1156-1166. doi: 10.1038/s41395-018-0107-7. Epub 2018 Jun 12.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2022-08390
Identifier Type: REGISTRY
Identifier Source: secondary_id
15-004540
Identifier Type: OTHER
Identifier Source: secondary_id
15-004540
Identifier Type: -
Identifier Source: org_study_id
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