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Specimen Collection Study for H. Pylori Testing

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ClinicalTrials.gov Identifier: NCT02970110
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Biomerica

Brief Summary:
The objective of this study is to acquire human specimens from subjects undergoing routine endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.

Condition or disease
Helicobacter Infections

Detailed Description:
This is a prospective study designed to acquire and bank human specimens from subjects who are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be conducted at a minimum of 2 sites in the United States. Investigator sites will enroll prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF) provided by the sponsor will be used to capture basic demographic information (DOB, age, gender, race/ethnicity), medication history, and related clinical information. The CRFs will also record the results of the following tests performed with the gastric biopsy tissue specimens: histology and rapid urease test (RUT).

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Specimen Collection Study for H. Pylori Testing in Patients With Dyspepsia
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019



Primary Outcome Measures :
  1. Non-invasive collection procedure [ Time Frame: 1 year ]
    This study is designed to collect specimens to supplement repository specimens for product validation purposes. The endoscopy results and specimens will be used in a future clinical trial of a non-invasive in vitro diagnostic assay for the detection of H. pylori antigen. institutional review board approval is sought in order to be able to use human specimens for validation of in vitro diagnostics.


Biospecimen Retention:   Samples Without DNA
Biospecimen


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will consist of subjects scheduled for routine upper endoscopy for upper gastrointestinal tract symptoms such as dyspepsia. All prospective subjects must be off of proton-pump inhibitors, antibiotics, and bismuth for at least 2 weeks prior to submission of the stool specimen and undergoing endoscopy.
Criteria

Inclusion Criteria:

  • Aged 21 and to 75 years.
  • Able to read, speak, and understand English or have access to a translator in subject's native language.
  • Patients without prior H. pylori eradication treatment.
  • Currently not on proton pump inhibitors, antibiotics or bismuth

    • Discontinuation at least 2 weeks prior to endoscopy and specimen collection.
  • Present with signs and symptoms of dyspepsia [e.g. upper abdominal discomfort or pain]
  • Undergo gastric biopsies as part of routine care
  • Physician able to provide histology and rapid urease result on biopsy specimens.

Exclusion Criteria:

  • Aged less than 21 years old or older than 75 years
  • Unable to provide consent.
  • Patients with a history of prior H. pylori eradication therapy.
  • Currently on proton pump inhibitors, antibiotics or bismuth and cannot or will not discontinue
  • Previous upper gastrointestinal surgery, such as bariatric surgery, Nissen fundoplication, or Roux-en-Y.
  • Any unstable or poorly-controlled medical or psychiatric condition.

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): NCT02970110


Contacts
Contact: Carolyn E Shoup 9496452111 ext 876 cshoup@biomerica.com
Contact: Elizabeth Laderman, Ph. D. 9496452111 ext 879 eladerman@biomerica.com

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: James L Buxbaum, MD    323-442-5100    James.Buxbaum@med.usc.edu   
Principal Investigator: James L Buxbaum, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212-1610
Contact: Tina Higgenbotham    615-322-4643    tina.higginbotham@vanderbilt.edu   
Principal Investigator: Douglas R Morgan, M.D., M.P.H.         
Sponsors and Collaborators
Biomerica
Investigators
Principal Investigator: Douglas R Morgan, M.D. MPH Vanderbilt University Medical Center

Responsible Party: Biomerica
ClinicalTrials.gov Identifier: NCT02970110     History of Changes
Other Study ID Numbers: HPY-COL-001
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Demographics including age, gender, geographical location, histology and RUT results collected in this study will be shared with researchers involved with a future evaluation of an in vitro diagnostic device product in development at Biomerica.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections