Identification of Biomarkers of Risk for Pre-neoplastic and Neoplastic Lesions for the Development of Gastric Cancer

Обзор

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.

Первичные конечные точки

• Evaluate the association between the levels of selected biomarkers and the diagnosis obtained after endoscopic examination and histological evaluation of the biopsies taken. [Срок оценки: 36 months]

Вторичные конечные точки (5)

• Evaluate the prognostic potential of baseline levels of the biomarkers analyzed [Срок оценки: 36 months]
• Identify biomarkers with the best relation with more advanced pre-neoplastic conditions and with neoplasia. [Срок оценки: 36 months]
• Compare the predictive accuracy of risk between the DSCb test and the DSCb test with the addition of the best-performing biomarker [Срок оценки: 36 months]
• Monitor test values during follow-up in subjects classified as high risk to assess the possible progression of the pre-neoplastic lesion [Срок оценки: 36 months]
• Monitor test values during follow-up in subjects with neoplasia to assess the potential of the test in therapeutic response [Срок оценки: 36 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• Centro di Riferimento Oncologico (CRO) di aviano-IRCCS — Aviano

Идентификаторы

NCT: NCT07374731 · CRO-2024-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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