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Trial record 2 of 6 for:    "johns hopkins" | Recruiting Studies | "gastric cancer" AND "Gastrointestinal Diseases"
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EsophaCap for the Detection of Early Esophageal Carcinoma

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ClinicalTrials.gov Identifier: NCT04214119
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 5, 2024
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief Summary:
This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma), and gastric cancer via sponge cytology.

Condition or disease
Barrett Esophagus Esophageal Cancer Gastric Cancer

Detailed Description:
This study is to identify potential biomarkers for the early detection of Barrett's Esophagus, esophageal carcinoma (both adenocarcinoma and squamous cell carcinoma). Esophageal and gastric cytology will be collected via sponge capsule. Candidate genes will be tested with DNA isolated from these samples in order to identify optimal biomarkers to differentiate between Barrett's esophagus and esophageal/gastric cancer versus normal esophageal/gastric tissue.
Study Design
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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: EsophaCap for the Detection of Early Esophageal Carcinoma
Actual Study Start Date : January 12, 2016
Estimated Primary Completion Date : December 19, 2025
Estimated Study Completion Date : December 19, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Groups and Cohorts
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Group/Cohort
Control
Patients age 18 or greater who have undergone esophagogastroduodenoscopy and does not have a diagnosis of Barrett's esophagus or esophageal/gastric malignancy.
Barrett's esophagus
Patients age 18 or greater who have undergone esophagogastroduodenoscopy and diagnosed with Barrett's esophagus via pathology.
Esophageal carcinoma
Patients age 18 or greater who have diagnosis of primary esophageal carcinoma.
Gastric cancer
Patients age 18 or greater who have diagnosis of primary esophageal cancer.


Outcome Measures
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Primary Outcome Measures :
  1. Difference in methylation of gene markers to discriminate Barrett's esophagus from non-pathological esophageal squamous and gastric cardia tissue. [ Time Frame: 1 day ]
    Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in Barrett's esophagus versus control in order to differentiate between subjects who have Barrett's esophagus and those who do not have Barrett's esophagus. This is measure using methylation index and the calculated probability score from different methylation index values.

  2. Difference in methylation of gene markers to discriminate esophageal carcinoma from non-pathological esophageal squamous and gastric cardia tissue. [ Time Frame: 1 day ]
    Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in esophageal cancer versus control in order to differentiate between subjects who have esophageal cancer and those who do not. This is measure using methylation index and the calculated probability score from different methylation index values.

  3. Difference in methylation of gene markers to discriminate gastric cancer from non-pathological esophageal squamous and gastric cardia tissue. [ Time Frame: 1 day ]
    Using DNA methylation, we plan on identifying, from a pool of highly selected marker candidates, the best biomarkers that are aberrantly methylated in gastric cancer versus control in order to differentiate between subjects who have gastric cancer and those who do not. This is measure using methylation index and the calculated probability score from different methylation index values.


Secondary Outcome Measures :
  1. Sensitivity of candidate biomarker p16 [ Time Frame: 1 day ]
    Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.

  2. Sensitivity of candidate biomarker NELL1 [ Time Frame: 1 day ]
    Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.

  3. Sensitivity of candidate biomarker AKAP12 [ Time Frame: 1 day ]
    Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.

  4. Sensitivity of candidate biomarker TAC1 [ Time Frame: 1 day ]
    Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.

  5. Sensitivity of candidate biomarker HPP1 [ Time Frame: 1 day ]
    Sensitivity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.

  6. Specificity of candidate biomarker p16 [ Time Frame: 1 day ]
    Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.

  7. Specificity of candidate biomarker NELL1 [ Time Frame: 1 day ]
    Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.

  8. Specificity of candidate biomarker AKAP12 [ Time Frame: 1 day ]
    Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.

  9. Specificity of candidate biomarker TAC1 [ Time Frame: 1 day ]
    Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.

  10. Specificity of candidate biomarker HPP1 [ Time Frame: 1 day ]
    Specificity of each candidate biomarker will be calculated by measuring the area under receiver operating characteristic curve generated from methylation index data.


Biospecimen Retention:   Samples With DNA
Esophageal and gastric brush cells.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for clinically indicated upper endoscopy will be approached to participate in this study.
Criteria

Inclusion Criteria:

  • Undergoing esophagogastroduodenoscopy at Johns Hopkins Hospital from 1/2016 to 12/2025
  • Age greater than 18 years
  • Patients must be able to swallow a capsule

Exclusion Criteria:

  • Patients in either arm with extra-esophageal malignancies including head and neck and gastric cancer
  • Patients who have undergone esophagectomy
  • Patients who have undergone radiation to the chest
  • Patients who are younger than 18
  • Patients with esophageal stents
  • Patients with esophageal strictures disabling passage of the capsule
Contacts and Locations
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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): NCT04214119


Contacts
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Contact: Stephen J Meltzer, M.D. 4105026071 smeltzer@jhmi.edu

Locations
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United States, Maryland
Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21205
Contact: Stephen J Meltzer, M.D.    410-502-6071    smeltzer@jhmi.edu   
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Stephen Meltzer, M.D.    410-502-6071    smeltzer@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Stephen Meltzer, M.D. Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04214119    
Other Study ID Numbers: IRB00072332
R01DK118250 ( U.S. NIH Grant/Contract )
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 5, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
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Digestive System Diseases
Gastrointestinal Diseases
Esophageal Neoplasms
Barrett Esophagus
Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Esophageal Diseases
Precancerous Conditions