Blood biomarker monitoring to detect early stomach pre-cancer and cancer risk
Identification of Biomarkers of Risk for Pre-neoplastic and Neoplastic Lesions for the Development of Gastric Cancer
This project will test whether regular fasting blood tests measuring pepsinogen and G17 gastrin can help identify adults at higher risk of stomach atrophy or cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Locations | 1 site (Aviano, Pordenone) |
| Trial ID | NCT07374731 on ClinicalTrials.gov |
What this trial studies
This observational program tracks circulating biomarkers—pepsinogen and G17 gastrin—in fasting adults who request pepsinogen testing, undergo gastroscopy, or have untreated gastric cancer. Participants provide serum samples for biomarker analysis and clinical/endoscopic data are linked when available to give context to marker changes. Biomarker levels are followed over time to detect worsening trends, and clinicians are alerted if values deteriorate. The goal is to offer dynamic, preventive surveillance to prompt timely diagnostic or therapeutic follow-up rather than to deliver an experimental treatment.
Who should consider this trial
Good fit: Adults (18+) who are fasting and request pepsinogen testing or gastroscopy, have suspected pre-neoplastic gastric lesions, or have gastric cancer before treatment and can give informed consent.
Not a fit: People under 18, pregnant women, patients with another malignancy within the past five years, or those unable to consent are excluded and therefore unlikely to receive benefit from this program.
Why it matters
Potential benefit: If successful, this monitoring could enable earlier detection of gastric atrophy or cancer and prompt timely follow-up that may improve outcomes.
How similar studies have performed: Previous studies have shown that pepsinogen and gastrin levels correlate with gastric atrophy and increased cancer risk, but routine longitudinal circulating biomarker monitoring as a preventive alert system is relatively under-tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged over 18; * Ability to understand, accept, and sign the informed consent form for the study; * Ability to understand, accept, and sign the consent form for data processing; * Ability to understand, accept, and sign the consent form for the collection of a serum sample for research purposes; * Patients who are fasting and have requested a pepsinogen test or gastroscopy, or who have gastric cancer prior to treatment; * Subjects who are fasting and have suspected pre-neoplastic/neoplastic gastric lesions or who have requested a pepsinogen test and for whom endoscopic examination data are available. Exclusion Criteria: * Patients under the age of 18 * Pregnant women * Patients with a coexisting or previous diagnosis of another malignant neoplasm in the last 5 years * Patients unable to understand, accept, and sign the consent form for data processing
Where this trial is running
Aviano, Pordenone
- Centro di Riferimento Oncologico (CRO) di aviano-IRCCS — Aviano, Pordenone, Italy (Recruiting)
Study contacts
- Principal investigator: Valli De Re — Centro di Riferimento Oncologico
- Study coordinator: Valli De Re, PhD
- Email: vdere@cro.it
- Phone: +39 0434 659672
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.