Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Pasteur
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years old or highter
written informed consent prior to any study procedure
Affiliated to a social insurance system
Untreated glandular atrophy (with or without intestinal metaplasia and/or dysplasia) and histologically diagnosed as of 2014
Disqualifiers
Autoimmune disease or disease that impacts the immune system (e.g: HIV)
Chronic inflammatory disease
Known evolutive cancer (excluding gastric cancer)
Treated in the last 3 months or currently treated with therapy that interferes with the immune system (e.g. immunosuppressive therapy)
Trial design
Design model
Parallel
Treatments tested in this trial
Additional blood collection as part of a blood sampling performed during routine care or specific for the research if not part of routine care.
Procedure/SurgeryCollection 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 collection
Procedure/SurgeryBlood sample collection (10 mL)
Treatment groups
2,500 Participants
are divided into 2 treatment groupsGroup A: Patients with gastric lesionOther 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
30 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institut Pasteur
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborator
Source ClinicalTrials.gov