search
Back to results

Diagnosis of Gastric Precancerous Lesions by a Blood Test GastroPanel in Patients With Increased Gastric Cancer Risk (GASTRO-PRA)

Primary Purpose

Gastric Cancer, Gastric Precancerous Lesions

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples analysis
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Cancer focused on measuring gastric cancer, gastric precancerous lesions, blood test

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing oesophagogastroduodenoscopy (EGD) according to usual care

  • Patients with increased risk of gastric cancer (at least one of the following criteria):

    • age > 50 years,
    • family cases of gastric cancer,
    • known precancerous lesions,
    • Biermer disease,
    • H. Pylori infection,
    • genetic predisposition (ex: Lynch syndrome),
    • MALT lymphoma,
    • dyspepsia.
  • Subjects affiliated with an appropriate social security system

Exclusion Criteria:

  • Subjects with known active cancer
  • Pregnancy
  • Patients receiving proton-pump inhibitors
  • Conditions that may interfere with the study objectives according to the investigator

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GastroPanel

Arm Description

GastroPanel test on blood samples

Outcomes

Primary Outcome Measures

Sensitivity of GastroPanel blood test
The pepsinogen I (PGI) level measure will be compared with the gold standard method (anatomopathological examination of gastric biopsy). Results will be expressed in accordance with Sydney system. Patients will be classified as ill if PGI<30µg/l, healthy if PGI >=30µg/l. The sensitivity of GastroPanel test will be calculated with their 95% confidence interval.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2015
Last Updated
December 3, 2015
Sponsor
Nantes University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02624271
Brief Title
Diagnosis of Gastric Precancerous Lesions by a Blood Test GastroPanel in Patients With Increased Gastric Cancer Risk
Acronym
GASTRO-PRA
Official Title
Non Invasive Diagnosis of Gastric Precancerous Lesions by GastroPanel Blood Test in Patients With Increased Gastric Cancer Risk : a French Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Despite the declining incidence, gastric cancer (GC) remains the second leading cause of cancer death worldwide. In France, it is the second digestive cancer with 7,000 new cases per year. It is now well demonstrated that patients with H. pylori infection, atrophic gastritis and intestinal metaplasia, have a high risk of developing GC. It is therefore important to detect these pre-neoplastic lesions at an early stage to improve patients prognosis. Thus, the aim of this project is to investigate the possible screening of gastric precancerous lesions by a blood test (GastroPanel®) in France, in patients with oesophagogastroduodenoscopy (EGD) prescription.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastric Precancerous Lesions
Keywords
gastric cancer, gastric precancerous lesions, blood test

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GastroPanel
Arm Type
Experimental
Arm Description
GastroPanel test on blood samples
Intervention Type
Other
Intervention Name(s)
blood samples analysis
Intervention Description
Analyze blood samples with GastroPanel test to detect gastric precancerous lesions.
Primary Outcome Measure Information:
Title
Sensitivity of GastroPanel blood test
Description
The pepsinogen I (PGI) level measure will be compared with the gold standard method (anatomopathological examination of gastric biopsy). Results will be expressed in accordance with Sydney system. Patients will be classified as ill if PGI<30µg/l, healthy if PGI >=30µg/l. The sensitivity of GastroPanel test will be calculated with their 95% confidence interval.
Time Frame
One assessment at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing oesophagogastroduodenoscopy (EGD) according to usual care Patients with increased risk of gastric cancer (at least one of the following criteria): age > 50 years, family cases of gastric cancer, known precancerous lesions, Biermer disease, H. Pylori infection, genetic predisposition (ex: Lynch syndrome), MALT lymphoma, dyspepsia. Subjects affiliated with an appropriate social security system Exclusion Criteria: Subjects with known active cancer Pregnancy Patients receiving proton-pump inhibitors Conditions that may interfere with the study objectives according to the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MATYSIAK BUDNIK Tamara, Pr
Phone
02 40 08 31 51
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MATYSIAK BUDNIK Tamara, Pr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MATYSIAK BUDNIK Tamara, Pr
Phone
02 40 08 31 51

12. IPD Sharing Statement

Learn more about this trial

Diagnosis of Gastric Precancerous Lesions by a Blood Test GastroPanel in Patients With Increased Gastric Cancer Risk

We'll reach out to this number within 24 hrs