Trial Title:
Circulating Biomarker Signatures for the Detection of Gastric Preneoplasia and Cancer
NCT ID:
NCT05854368
Condition:
Gastric Lesion
Gastric Precancerous Condition
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Precancerous Conditions
Conditions: Keywords:
Gastric Cancer, biomarkers,
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients with gastric lesion (including preneoplasia or cancer) and Healthy Volunteers
(control)
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Additional blood collection as part of routine care
Description:
Collection of an additional blood volume (10mL) as part of a blood sampling performed
during routine care or specific for the research if not part of routine care.
Arm group label:
Patients with gastric lesion
Intervention type:
Procedure
Intervention name:
Blood collection
Description:
Blood sample collection (10 mL)
Arm group label:
Control
Summary:
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 (10mL) 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 (10 ml) will be drawn specifically
for this study
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Common
- 18 years old or highter
- written informed consent prior to any study procedure
- Affiliated to a social insurance system
Specific to patients with gastric lesions
- Untreated glandular atrophy (with or without intestinal metaplasia and/or dysplasia)
and histologically diagnosed as of 2014
- Treatment naïve Gastric cancer (distal or proximal adenocarcinoma)
Exclusion Criteria:
Common
- 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)
- Current treatment with long-term corticosteroid therapy
- Current treatment with long-term nonsteroidal anti-inflammatory drugs
- Pregnant woman or breastfeeding
- Patient or healthy volunteer under legal protection (e.g. guardianship)
- Patient or healthy volunteer currently participating to a clinical trial evaluating
either an experimental medical product or a medical device
- Patient or healthy volunteer currently in custody
Specific to Healthy Volunteer
- Known history of Helicobacter pylori infection
- Known history of gastric lesions (i.e. chronic gastritis, gastric atrophy,
intestinal metaplasia, dysplasia and cancer)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ambroise Paré Teaching Hospital (AP-HP)
Address:
City:
Boulogne-Billancourt
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Dominique LAMARQUE, MD, PhD
Facility:
Name:
Beaujon Teaching Hospital (AP-HP)
Address:
City:
Clichy
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Frédéric PRAT, MD, PhD
Facility:
Name:
Kremlin Bicêtre Teaching Hospital (AP-HP)
Address:
City:
Le Kremlin-Bicêtre
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Aurélien AMIOT, MD, PhD
Facility:
Name:
Cochin Teaching Hospital (AP-HP)
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Romain CORIAT, MD, PhD
Facility:
Name:
ICAReB - Investigation clinique (Institut Pasteur)
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Hélène LAUDE, MD
Facility:
Name:
Saint Antoine Teaching Hospital (AP-HP)
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Xavier DRAY, MD, PhD
Start date:
July 3, 2023
Completion date:
July 2025
Lead sponsor:
Agency:
Institut Pasteur
Agency class:
Industry
Collaborator:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Institut Pasteur
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05854368
