Recruiting

MicroRNA Expression

Sponsor:

Midwest Biomedical Research Foundation

Code:

NCT02464930

Conditions

Barrett's Esophagus

Gastroesophageal Reflux

Esophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The primary purpose of this study is to test new methods to diagnose BE in time before it turns into advanced cancer. Once BE is diagnosed, the current standard of care is to monitor the disease so that complication such as cancer can be diagnosed early. The two new methods the investigators are evaluating are: a) blood test and b) brush test of the food pipe. The investigators will collect blood, bile and cells from the food pipe and stomach and measure for a biomarker called microRNA (miRNA). In the future, measurements of microRNA biomarkers could help the doctors figure out which patients are at increased risk for cancer of the esophagus.

Conditions

Barrett's Esophagus

Gastroesophageal Reflux

Esophageal Adenocarcinoma

Study ID

NCT02464930

Start date

Apr, 2015

Status verified date

Jun, 2015

Completion date

Dec, 2018

Anticipated

Primary completion date

Apr, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patient age: > 18 years
  • Ability to provide written, informed consent

Exclusion Criteria:

  • Pregnancy or planning a pregnancy
  • History of nasal, esophageal \& gastric surgery
  • History of recurrent epistaxis or nasal trauma
  • Subjects with a history of unresolved drug or alcohol dependency
  • Inability to obtain biopsies due to a coagulopathy, varices, thrombocytopenia, etc.
  • Subjects with inadequate cytology specimens will not undergo repeat test and will be excluded from the study
  • Inability to provide written informed consent
  • Inability to discontinue drugs such as Plavix
  • Advanced chronic liver disease
  • Severe uncontrolled coagulopathy
  • Active cancer in any organ over the past 3 years.

Study Design

Enrollment

220 participants

Anticipated

Interventions and Outcome Measures

Arms

No-GERD Controls

NERD controls will be enrolled from subjects presenting to the endoscopy unit who are being evaluated for reasons other than GERD or BE surveillance. These are patients who are referred to the endoscopy unit for: evaluation of anemia, dysphagia, occult blood positivity, gastrointestinal blood loss etc.

  • No history of GERD
  • Response "no" to presence of symptoms on a standardized GERD questionnaire
  • No prescriptions for acid suppressive medication over the past 2 years as documented in electronic pharmacy records.
  • Normal endoscopy that does not find Barrett's esophagus, hiatus hernia or erosive esophagitis.

GERD Controls

  • Respond "yes" to the presence of symptoms on a standardized GERD questionnaire
  • Prescriptions for acid suppressive medication as documented in electronic pharmacy records.

BE Cases

• Patients who present for evaluation of reflux symptoms and are found to have at least 1 cm of columnar lined esophagus on endoscopy with intestinal metaplasia on biopsies. This will include patients with esophageal adenocarcinoma

Primary outcome measure

  • Sensitivity and specificity of tissue and serum microRNA expression by digital polymerase chain reaction for diagnosis of BE neoplasia [ Time Frame: 1-3 years ]

Central Contacts and Locations

Central contacts

Ajay Bansal, MD

57790ajay.bansal@va.gov

Andrew Price, BS

56428andrew.price@va.gov

Locations

Kansas City Veterans Affairs Medical Center

Recruiting

Kansas City, Missouri, United States, 64128

Contacts

AJAY BANSAL, MD

816-861-4700Ajay.Bansal@va.gov

Andrew Price, AS

816-861-4700Andrew.Price2@va.gov

Principal Investigator:

Ajay Bansal

More Information

Sponsor

Midwest Biomedical Research Foundation

Last update posted

Jun 8, 2015

Last verified

Jun, 2015

Keywords

  • Blood
  • Cytology
  • Esophagus
  • microRNA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Midwest Biomedical Research Foundation on 2015-06-08.