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RecruitingNCT07374731DSCb scoreUpdated Feb 2, 2026

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

An observational study in Gastric Cancer, sponsored by Centro di Riferimento Oncologico - Aviano. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Centro di Riferimento Oncologico - Aviano · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
192
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Cancer

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 192 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Centro di Riferimento Oncologico - Aviano is the lead sponsor of 47 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
192 participants (estimated)
Patient registry
No
06

What researchers measure

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

    Time frame: 36 months

Secondary outcomes

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

    Mean difference of biomarkers between responders and non responders

    Time frame: 36 months

  2. Identify biomarkers with the best relation with more advanced pre-neoplastic conditions and with neoplasia.

    Mean difference of biomarkers level in subgroups of patients with the condition under investigation

    Time frame: 36 months

  3. Compare the predictive accuracy of risk between the DSCb test and the DSCb test with the addition of the best-performing biomarker

    Accuracy will be calculated as number of patients correctly classified over the total number of patients.

    Time frame: 36 months

  4. Monitor test values during follow-up in subjects classified as high risk to assess the possible progression of the pre-neoplastic lesion

    Likelihood ratio of the two tests will be reported

    Time frame: 36 months

  5. Monitor test values during follow-up in subjects with neoplasia to assess the potential of the test in therapeutic response

    Test will be compared by mean of ROC curve analysis

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
  • Centro di Riferimento Oncologico (CRO) di aviano-IRCCS
    Aviano, Pordenone 33081, Italy
    • Valli De Re, PhD · Contact · vdere@cro.it · +39 0434 659672
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07374731
Lead sponsor
Centro di Riferimento Oncologico - Aviano
Responsible party
Sponsor
First posted
Jan 29, 2026
Start date
May 21, 2025
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Feb 2, 2026

Study contacts

Valli De Re, PhD
Contact
vdere@cro.it
+39 0434 659672
Valli De Re
principal investigator · Centro di Riferimento Oncologico

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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