Gastric CancerDSCb scoreNCT07374731
Identification of Biomarkers of Risk for Pre-neoplastic and Neoplastic Lesions for the Development of Gastric Cancer
An observational study of Gastric Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastric Cancer
- How many people
- 192 participants
- Where
- 1 siteItaly
- Study dates
- 21 May 2025to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncologico (CRO) di aviano-IRCCS
Aviano, Pordenone, 33081
Valli De Re, PhD, +39 0434 659672, vdere@cro.it
About this study
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.
Read more
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.
- Conditions
- Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 months
Secondary outcomes (5)
Evaluate the prognostic potential of baseline levels of the biomarkers analyzed
Mean difference of biomarkers between responders and non responders
Measured: 36 months
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
Measured: 36 months
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.
Measured: 36 months
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
Measured: 36 months
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start21 May 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valli De Re, Principal investigator, Centro di Riferimento Oncologico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374731
- Sponsor's protocol ID
- CRO-2024-04
- Acronym
- DSCb score
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers of Risk for Pre-neoplastic and Neoplastic Lesions for the Development of Gastric Cancer
- ClinicalTrials.gov ID
- NCT07374731
- Acronym / sponsor ID
- DSCb score / CRO-2024-04
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valli De Re principal investigator
Centro di Riferimento Oncologico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valli De Re, PhD (+39 0434 659672, vdere@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.