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Trial record 7 of 10 for:    Recruiting, Not yet recruiting, Available Studies | "Stomach Ulcer"

Helicobacter Pylori Sample Collection Protocol Pre Therapy Subjects

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ClinicalTrials.gov Identifier: NCT03060746
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
DiaSorin Inc.

Brief Summary:
The primary objective is to obtain stool samples from pre-therapy subjects already undergoing evaluation for an H. pylori infection by upper esophagogastroduodenoscopy (EGD) and gastric biopsy.

Condition or disease Intervention/treatment
Helicobacter Pylori Infection Gastric Ulcer Nausea Abdominal Pain Weight Loss Stomach Ulcer Loss of Appetite Bloating Other: Newly Diagnosed

Detailed Description:
Stools will be collected and tested, at a later date, in a clinical performance study with an investigational H. pylori antigen assay. This study will be coordinated by the Sponsor.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Helicobacter Pylori Sample Collection Protocol PRE-THERAPY
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Intervention Details:
  • Other: Newly Diagnosed
    Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample


Primary Outcome Measures :
  1. Helicobacter pylori Stool Collection [ Time Frame: Through Study Completion, an average of 1 year ]
    In vitro diagnostic (IVD) device performance


Biospecimen Retention:   Samples Without DNA
Human Stool


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing EGD with biopsy for H. pylori diagnosis
Criteria

Inclusion Criteria:

  • Adult ≥ 22 years, either gender
  • Subject is symptomatic showing signs and symptoms of gastritis
  • Subject is not under evaluation for post-therapy follow up diagnosis
  • Subject is already undergoing upper EGD and obtaining a gastric biopsy as part of routine care for H. pylori diagnosing
  • Biopsy is obtained from antrum and/or corpus and is tested by CRM
  • At least two of the three CRM tests are performed
  • Subject whose EGD with biopsy procedure occurred ≤ 7 days prior to stool collection
  • Willing and able to sign the IRB approved Informed Consent form for this project, or able to provide Informed Consent in accordance with 21 CFR 50 Subpart B

Exclusion Criteria:

  • Any subject that does not meet the inclusion criteria
  • Subject with current severe H. pylori infection
  • Subject ingested compounds that may interfere with detection of H. pylori e.g. 4 weeks for all antibiotics, 2 weeks for Bismuth preparations or proton pump inhibitors prior to EGD/collection
  • Subject recently tested, less than 3 months and knowledge of H. pylori absence
  • Subject tested, less than one year and knowledge of H. pylori presence but NOT undergone prescribed treatment
  • Pregnant or lactating
  • Inability or unwilling to perform required study procedures
  • Subject is unable or unwilling to provide informed consent

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): NCT03060746


Contacts
Contact: Clinical @DiaSorin.com 651-439-9710 Clinical@diasorin.com

Locations
United States, Arizona
One (1) Location in Arizonia Suspended
Mesa, Arizona, United States, 85206
United States, California
One (1) Location in Beverly Hills, California Terminated
Beverly Hills, California, United States, 90067
One (1) Location in Mission Hills, California Recruiting
Mission Hills, California, United States, 91345
One (1) Location in Oxnard, California Recruiting
Oxnard, California, United States, 93030
United States, Florida
One (1) Location in Florida Recruiting
Palm Harbor, Florida, United States, 34684
United States, Missouri
One (1) Location in Missouri Suspended
Saint Louis, Missouri, United States, 63141
United States, New York
One (1) Location in Great Neck, New York Recruiting
Great Neck, New York, United States, 11023
United States, North Carolina
One (1) Location in North Carolina Recruiting
Asheville, North Carolina, United States, 28801
United States, Ohio
One (1) Location in Ohio Recruiting
Mentor, Ohio, United States, 44060
United States, South Carolina
One (1) Location in Greenville, South Carolina Recruiting
Greenville, South Carolina, United States, 29615
United States, Texas
One (1) Location in Houston, Texas Recruiting
Houston, Texas, United States, 77030
United States, Virginia
One (1) Location in Virginia Recruiting
Chesapeake, Virginia, United States, 23320
Italy
One (1) Location in Bologna, Italy Recruiting
Bologna, Italy
Sponsors and Collaborators
DiaSorin Inc.
ICON Clinical Research

Responsible Party: DiaSorin Inc.
ClinicalTrials.gov Identifier: NCT03060746     History of Changes
Other Study ID Numbers: PRE-TREAT A001
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Stomach Ulcer
Ulcer
Weight Loss
Abdominal Pain
Helicobacter Infections
Anorexia
Pathologic Processes
Body Weight Changes
Body Weight
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms, Digestive
Gram-Negative Bacterial Infections
Bacterial Infections
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases