Identification of Biomarkers of Risk for Pre-neoplastic and Neoplastic Lesions for the Development of Gastric Cancer
DSCb score
1 other identifier
observational
192
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2025
CompletedFirst Submitted
Initial submission to the registry
January 21, 2026
CompletedFirst Posted
Study publicly available on registry
January 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
February 2, 2026
January 1, 2026
1.7 years
January 21, 2026
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the association between the levels of selected biomarkers and the diagnosis obtained after endoscopic examination and histological evaluation of the biopsies taken.
The mean value of biomarkers level in positive and negative biopsy will be evaluated
36 months
Secondary Outcomes (5)
Evaluate the prognostic potential of baseline levels of the biomarkers analyzed
36 months
Identify biomarkers with the best relation with more advanced pre-neoplastic conditions and with neoplasia.
36 months
Compare the predictive accuracy of risk between the DSCb test and the DSCb test with the addition of the best-performing biomarker
36 months
Monitor test values during follow-up in subjects classified as high risk to assess the possible progression of the pre-neoplastic lesion
36 months
Monitor test values during follow-up in subjects with neoplasia to assess the potential of the test in therapeutic response
36 months
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro di Riferimento Oncologico (CRO) di aviano-IRCCS
Aviano, Pordenone, 33081, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valli De Re
Centro di Riferimento Oncologico
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2026
First Posted
January 29, 2026
Study Start
May 21, 2025
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
February 2, 2026
Record last verified: 2026-01