Identification of Biomarkers of Risk for Pre-neoplastic and Neoplastic Lesions for the Development of Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gastric Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (5)
- Evaluate the prognostic potential of baseline levels of the biomarkers analyzed [Time frame: 36 months]
- Identify biomarkers with the best relation with more advanced pre-neoplastic conditions and with neoplasia. [Time frame: 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]
- 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]
- Monitor test values during follow-up in subjects with neoplasia to assess the potential of the test in therapeutic response [Time frame: 36 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Centro di Riferimento Oncologico (CRO) di aviano-IRCCS — Aviano
Identifiers
NCT: NCT07374731 · CRO-2024-04