NCT05854368|Recruiting
Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer
PREGASIGN#1
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PREGASIGN#1
Sponsor study identifier
interventional
2,500
1 country
8
Study Start
July 3, 2023
Actual (reported)Primary Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The goal of this study is to characterize and validate a signature of circulating biomarkers in plasma, associated with the presence of gastric preneoplasia in patients with preexisting gastric lesion compared with a control group. For this purpose:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2023
Actual (reported)May 11, 2023
Actual (reported)July 3, 2023
Actual (reported)December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Characterization and validation of a signature combining plasmatic proteins related to inflammation and carcinogenesis process, associated with the presence of gastric mucosal dysplasia lesions compared with an H. pylori negative control group.
From the plasma obtained from patients previously diagnosed by gastric endoscopy for the presence of dysplasia in the gastric mucosa and that have signed a prior consent form, the concentration of protein biomarker candidates will be determined using a bead-based immunoassay according to Luminex® technology. It will be expressed as amount per ml of plasma. For each protein constituting the signature of biomarkers, its levels in the plasma of patients with dysplasia will be compared to the corresponding levels in healthy subjects with a negative H. pylori serology and referred as a control group.
30 months
Characterization and validation of a signature combining plasmatic proteins related to inflammation and carcinogenesis process, associated with the presence of glandular atrophy lesions compared with an H. pylori negative control group.
30 months
Characterization and validation of a signature combining plasmatic proteins related to inflammation and carcinogenesis process, associated with the presence of intestinal metaplastic lesions compared with an H. pylori negative control group.
30 months
Characterization and validation of a signature combining plasmatic proteins related to inflammation and carcinogenesis process, associated with the presence of proximal gastric adenocarcinoma compared with an H. pylori negative control group.
30 months
Characterization and validation of a signature combining plasmatic proteins related to inflammation and carcinogenesis process, associated with the presence of distal gastric adenocarcinoma compared with an H. pylori negative control group.
30 months
Characterization of the plasma levels of the proteins biomarker composing these signatures specific for the different stages of gastric cancer cascade, between the different studied pathology groups
Patients with: * Gastric epithelial dysplasia * Glandular atrophy of the gastric mucosa * Intestinal metaplasia of the gastric mucosa * Proximal gastric adenocarcinoma * Distal gastric adenocarcinoma
Healthy Volunteers
Collection of an additional blood volume (9 mL) as part of a blood sampling performed during routine care or specific for the research if not part of routine care.
Blood sample collection (10 mL)
Ambroise Paré Teaching Hospital (AP-HP)
Boulogne-Billancourt, France
Beaujon Teaching Hospital (AP-HP)
Clichy, France
Kremlin Bicêtre Teaching Hospital (AP-HP)
Le Kremlin-Bicêtre, France
Kotilea K, Bontems P, Touati E. Epidemiology, Diagnosis and Risk Factors of Helicobacter pylori Infection. Adv Exp Med Biol. 2019;1149:17-33. doi: 10.1007/5584_2019_357.
Dominique LAMARQUE, MD, PhD
Ambroise Paré Teaching Hospital (AP-HP)
First Submitted
February 8, 2023
First Posted
May 11, 2023
Study Start
July 3, 2023
Actual (reported)Primary Completion
December 2025
Sexual Dysfunction in Cirrhosis
30 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Cochin Teaching Hospital (AP-HP)
Paris, France
INVOLvE - Investigation et volontaires en santé humaine (Institut Pasteur)
Paris, France
Saint Antoine Teaching Hospital (AP-HP)
Paris, France
Saint Antoine Teaching Hospital (AP-HP)
Paris, France
Saint Louis Teaching Hospital (AP-HP)
Paris, France
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 16, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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