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NCT Number: NCT07374731

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro di Riferimento Oncologico (CRO) di aviano-IRCCS

Aviano, Pordenone, 33081, Italy

Location status: Recruiting

Location contact

Valli De Re, PhD

CONTACT

[email protected]

+39 0434 659672

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    Time frame: 36 months

    The mean value of biomarkers level in positive and negative biopsy will be evaluated

Secondary outcomes

  1. Evaluate the prognostic potential of baseline levels of the biomarkers analyzed

    Time frame: 36 months

    Mean difference of biomarkers between responders and non responders

  2. 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

  3. 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.

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Valli De Re, PhD

CONTACT

[email protected]

+39 0434 659672

Sponsors and collaborators

Lead sponsor

Centro di Riferimento Oncologico - Aviano

Other

Registry information

Acronym: DSCb score

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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