Identification of Biomarkers of Risk for Pre-neoplastic and Neoplastic Lesions for the Development of Gastric Cancer (DSCb score)

January 29, 2026 updated by: Centro di Riferimento Oncologico - Aviano

Investigator propose the implementation of circulating biomarker monitoring, focusing on molecules related to the progression of gastric atrophy and/or associated with gastric cancer.

Monitoring these biomarkers will provide gastroenterologists with timely information on individuals at risk and, if values worsen during follow-up, will alert physicians observing these patients to evaluate them.

This monitoring will be offered to individuals who contact the IBO (Immunopatologia e Biomarcatori Oncologici) Unit at CRO (Centro di Riferimento Oncologico) in Aviano requesting an assessment of gastric function through pepsinogen and G17 gastrin level testing. Monitoring these biomarkers will provide a dynamic analysis of patients' gastric status, allowing for timely intervention in case of deviations from normal values. This proactive approach is important for the preventive management of gastric diseases, particularly for the diagnosis and monitoring of gastric atrophy and gastric cancer.

The IBO unit of the CRO in Aviano, together with the pathological anatomy and clinical units of gastroenterology, medical oncology, and surgery, will play a role in coordinating and implementing this monitoring program, thus contributing to the promotion of gastric health and the prevention of associated diseases.

Study Overview

Status

Recruiting

Conditions

Gastric Cancer

Study Type

Observational

Enrollment (Estimated)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Valli De Re, PhD
Phone Number: +39 0434 659672
Email: vdere@cro.it

Study Locations

Italy
- Pordenone
  - Aviano, Pordenone, Italy, 33081
    - Recruiting
    - Centro di Riferimento Oncologico (CRO) di aviano-IRCCS
    - Contact:
      
      Valli De Re, PhD
      
      Phone Number: +39 0434 659672
      
      Email: vdere@cro.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

The study will be divided into two patient cohorts:

a retrospective cohort comprising biological material (serum) stored at the IBO unit of the CRO in Aviano and/or at the Biobank since 2014 from subjects with suspected gastric lesions or gastric cancer;
a prospective cohort of subjects with prescriptions for pepsinogen and G17 gastrin testing. Selection will be made from among those who present at the CRO blood collection room in Aviano, in gastroenterology, or who are admitted to medical oncology or surgery for gastric cancer. Hospitalized patients will undergo fasting blood sampling before therapy or surgery. Subjects belonging to high-risk categories or diagnosed with neoplasia will undergo a second blood sampling during follow-up to monitor any disease progression or therapeutic response.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the association between the levels of selected biomarkers and the diagnosis obtained after endoscopic examination and histological evaluation of the biopsies taken. Time Frame: 36 months	The mean value of biomarkers level in positive and negative biopsy will be evaluated	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the prognostic potential of baseline levels of the biomarkers analyzed Time Frame: 36 months	Mean difference of biomarkers between responders and non responders	36 months
Identify biomarkers with the best relation with more advanced pre-neoplastic conditions and with neoplasia. Time Frame: 36 months	Mean difference of biomarkers level in subgroups of patients with the condition under investigation	36 months
Compare the predictive accuracy of risk between the DSCb test and the DSCb test with the addition of the best-performing biomarker Time Frame: 36 months	Accuracy will be calculated as number of patients correctly classified over the total number of patients.	36 months
Monitor test values during follow-up in subjects classified as high risk to assess the possible progression of the pre-neoplastic lesion Time Frame: 36 months	Likelihood ratio of the two tests will be reported	36 months
Monitor test values during follow-up in subjects with neoplasia to assess the potential of the test in therapeutic response Time Frame: 36 months	Test will be compared by mean of ROC curve analysis	36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro di Riferimento Oncologico - Aviano

Investigators

Principal Investigator: Valli De Re, Centro di Riferimento Oncologico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria