Actively Recruiting
SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up
Led by Instituto Portugues de Oncologia, Francisco Gentil, Porto · Updated on 2022-03-31
912
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people with precancerous stomach conditions such as gastric atrophy and intestinal metaplasia, which can lead to gastric cancer. This study aims to describe these conditions using clinical history, tissue analysis (histology), and endoscopic imaging with validated scoring systems. It also seeks to track how these conditions change over time and to estimate the risk of gastric cancer based on endoscopic grading. The goal is to determine the best method and timing for endoscopic surveillance in different patient groups. Participants aged over 45 undergoing upper gastrointestinal endoscopy will be examined using high-resolution endoscopy with virtual chromoendoscopy. Biopsies will be taken either from suspicious areas or random locations in the stomach to stage the condition histologically. All patients testing positive for Helicobacter pylori infection will receive treatment to eradicate it. Patients with higher risk scores will be randomly assigned to receive endoscopic follow-up yearly or every three years for six years. Those with moderate risk will have observational follow-up at 3 and 6 years. Low-risk individuals will be offered a follow-up endoscopy six years later. During the study, participants will have clinical consultations and endoscopic examinations with biopsy sampling as needed. Data on tissue changes and endoscopic findings will be collected in a database. The main outcomes evaluated after six years include the development of dysplasia and carcinoma. Secondary outcomes include measures related to cancer treatment criteria and advanced gastric cancer. This structured follow-up will help define the optimal surveillance strategy based on clinical, histological, and endoscopic factors.
CONDITIONS
Brief Title
SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for upper GI endoscopy with indication for gastric biopsies, including those with known gastric pathology or premalignant conditions
- Age above 45 years old
You will not qualify if you...
- History of previous gastrectomy
- History of endoscopic resection of neoplastic lesion
- History of previous gastric dysplasia
- Hereditary syndromes that increase gastric cancer risk (familial adenomatous polyposis; Lynch syndrome)
- Serious comorbidities (ASA 3 or more)
- Medication with anticoagulants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure at baseline
Participants undergo upper gastrointestinal endoscopy with biopsies to assess premalignant gastric conditions using validated scales.
1 visit (in-person)
Duration - Up to 6 years
Participants with premalignant gastric conditions are followed with individualized endoscopic surveillance according to risk stage.
Yearly or every three years endoscopic visits depending on risk group
Trial Site Locations
Total: 1 location
1
IPO-Porto
Porto, Portugal, 4200-072
Actively Recruiting
Research Team
P
Pedro Pimentel-Nunes, MD PhD
D
Diogo Libanio, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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