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: * Patients with pre-existing gastric lesions will be invited to participate to this study. If they are willing to participate an additional blood sample (9 mL) will be collected at the time of the blood collection performed during their routine care * Healthy subjects will be invited to participate to constitute the control group. If they are willing to participate a blood sample (9 ml) will be drawn specifically for this study
Gastric cancer (GC) is the fourth cause of cancer-related death and the fifth most common diagnosed cancer worldwide with 1 million new cases per year. GC is mainly associated with a poor prognosis, highlighting the importance of its early detection. GC results from a multistep process starting from a gastric chronic inflammation preceding atrophic gastritis (AG), the development of preneoplasia (intestinal metaplasia (IM), dysplasia (Dys) and then cancer lesions. Presently, GC can only be diagnosed by endoscopy, which is an invasive, and costly method with its limits. Indeed, preneoplasia as Dys can escape endoscopic detection. Therefore, the discovery of blood-based biomarkers to identify the presence of gastric preneoplasia and/or cancer lesions at the earliest, at an asymptomatic stage, is of paramount interest. It is crucial not only for the early detection/prevention of individuals at risk of GC but also useful for patient follow-up to predict disease recurrence/outcome and to monitor treatment. Using plasma samples from patients at various stages of the GC cascade, we previously identified two signatures of 6 protein candidates to predict the presence of preneoplasia and GC lesions. Based on these data, the goal of this study is to further test and validate these different signatures, and to improve their predictive ability at the earliest stages of the GC cascade, taking into account the different types of gastric preneoplasia, IM and Dys, and their grade of severity. To achieve this goal, a large multicentric cohort of patients will be established including different groups of plasma samples covering the most complete panel of the type/grades of gastric preneoplasia as well as at early stages of GC. These plasma samples will be then used to measure the level of the different signature components using various method of analysis as immuno-based assays.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
2,500
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
COMPLETEDBeaujon Teaching Hospital (AP-HP)
Clichy, France
RECRUITINGKremlin Bicêtre Teaching Hospital (AP-HP)
Le Kremlin-Bicêtre, France
RECRUITINGCochin Teaching Hospital (AP-HP)
Paris, France
RECRUITINGINVOLvE - Investigation et volontaires en santé humaine (Institut Pasteur)
Paris, France
RECRUITINGSaint Antoine Teaching Hospital (AP-HP)
Paris, France
RECRUITINGSaint Antoine Teaching Hospital (AP-HP)
Paris, France
NOT_YET_RECRUITINGSaint Louis Teaching Hospital (AP-HP)
Paris, France
NOT_YET_RECRUITINGCharacterization 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.
Time frame: 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.
From the plasma obtained from patients previously diagnosed by gastric endoscopy for the presence of glandular atrophy lesions 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 gastric glandular atrophy lesions will be compared to the corresponding levels in healthy subjects with a negative H. pylori serology and referred as a control group.
Time frame: 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.
From the plasma obtained from patients previously diagnosed by gastric endoscopy for the presence of intestinal metaplastic lesions within 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 gastric intestinal metaplastic lesions will be compared to the corresponding levels in healthy subjects with a negative H. pylori serology and referred as a control group.
Time frame: 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.
From the plasma obtained from patients previously diagnosed by gastric endoscopy for the presence of proximal gastric adenocarcinoma 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 proximal gastric adenocarcinoma will be compared to the corresponding levels in healthy subjects with a negative H. pylori serology and referred as a control group.
Time frame: 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.
From the plasma obtained from patients previously diagnosed by gastric endoscopy for the presence of distal gastric adenocarcinoma 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 distal gastric adenocarcinoma will be compared to the corresponding levels in healthy subjects with a negative H. pylori serology and referred as a control group.
Time frame: 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
From the plasma obtained from patients previously diagnosed by gastric endoscopy for the presence of gastric lesions at the different stages of the gastric cancer cascade (dysplasia, glandular atrophy, intestinal metaplasia, proximal gastric adenocarcinoma and distal gastric adenocarcinoma), 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 plasma levels will be compared between patients from the different groups of gastric lesions dysplasia, glandular atrophy, intestinal metaplasia, proximal gastric adenocarcinoma and distal gastric adenocarcinoma).
Time frame: 30 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.