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The Analysis of WATS3D (Wide Area Transepithelial Sample Biopsy With 3-Dimensional Computer-Assisted Analysis) Increased Yield of Barrett's Esophagus and Esophageal Dysplasia

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ClinicalTrials.gov Identifier: NCT03008980
Recruitment Status : Recruiting
First Posted : January 4, 2017
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
Rockford Gastroenterology Associates
Icahn School of Medicine at Mount Sinai
Temple University
University of Rochester
University of Kansas Medical Center
NYU Langone Health
Information provided by (Responsible Party):
CDx Diagnostics

Brief Summary:
Patients will be recruited from participating institutions prior to planned routine care EGD with WATS3D brush samples and forceps biopsies. Eligibility will be reviewed and patients who are potentially eligible for the study will be approached regarding the study. If interested, participants will be consented and proceed with routine care EGD. The study coordinator or other research personnel will document information from the routine care endoscopy as part of this research study. Follow-up information collected will include WATS3D cytology and forceps biopsy pathology results from any routine care endoscopy performed during the course of participation in the study, any surgeries received and related to their condition, and any other care received as part of their condition. WATS3D samples will be sent to CDx Diagnostics for analysis.

Condition or disease Intervention/treatment
GERD Barrett Esophagus Esophageal Dysplasia Esophagus Adenocarcinoma Other: Diagnostic Test

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Study Type : Observational
Estimated Enrollment : 75000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : March 2002
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
Community GI Group
Diagnostic Test
Other: Diagnostic Test
Academic GI Group
Diagnostic Test
Other: Diagnostic Test
Academic Esophageal Dysplasia and Cancer
Diagnostic Test
Other: Diagnostic Test
Community Barrett's Esophagus Screening
Diagnostic Test
Other: Diagnostic Test
Community Esophageal Dysplasia
Diagnostic Test
Other: Diagnostic Test
Post-Ablation BE and Esophagus Dysplasia
Diagnostic Test
Other: Diagnostic Test
GERD, BE, and Esophageal Dysplasia
Diagnostic Test
Other: Diagnostic Test



Primary Outcome Measures :
  1. Outcomes of patients undergoing WATS sampling. Specifically incremental yield for Barrett's Esophagus and Esophageal Dysplasia due to WATS sampling above that noted from routine forceps biopsies in various clinical settings. [ Time Frame: up to 18 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with esophageal disease
Criteria

Inclusion Criteria:

  1. Both males and females at least 18 years of age undergoing EGD to evaluate signs or symptoms suggestive of upper gastrointestinal disease.
  2. Patients with known GERD undergoing a screening EGD with accompanying WATS3D biopsies and forceps biopsies.
  3. Patients with known BE undergoing a surveillance EGD with accompanying WATS3D biopsies and forceps biopsies.
  4. Patients with a known prior history (recent or remote) of dysplasia of either indefinite, low grade or high-grade, or intramucosal adenocarcinoma undergoing a surveillance EGD with accompanying WATS3D biopsies and forceps biopsies.
  5. Patients who have undergone radiofrequency ablation orcryoablation who are undergoing surveillance EGD with accompanying WATS3D biopsies and forceps biopsies will be included in the study. The results of this group of patients will be analyzed separately from patients undergoing screening and surveillance who have not been ablated.
  6. Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.

Exclusion Criteria:

  1. Patients who on their initial evaluation have a visible highly suspicious lesion, such as a nodule or ulcer, (noted while undergoing endoscopy) that requires targeted biopsy will be excluded from the study.
  2. Patients who do not undergo both Forceps Biopsy and WATS3D biopsy of the esophagus. Subsequent endoscopic evaluation may include forceps biopsies alone, WATS3D biopsies alone, both forceps and WATS3D biopsies, or no biopsies.
  3. Patients with visible lesions that are either submucosal or covered with intact epithelium.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008980


Contacts
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Contact: Rivka Rotberg 845-368-7444 rrotberg@cdxdiagnostics.com
Contact: Stephanie Pille 845-368-7452 pstephanie@cdxdiagnostics.com

Locations
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United States, Pennsylvania
Mike Smith Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Mike Smith, MD         
Sponsors and Collaborators
CDx Diagnostics
Rockford Gastroenterology Associates
Icahn School of Medicine at Mount Sinai
Temple University
University of Rochester
University of Kansas Medical Center
NYU Langone Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CDx Diagnostics
ClinicalTrials.gov Identifier: NCT03008980     History of Changes
Other Study ID Numbers: CDx 103
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Adenocarcinoma
Barrett Esophagus
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases