Metastatic Gastric CancerNCT06877910
Deciphering the Molecular Traits of Non-canonical Responders to Advance Personalized Therapy in Gastric Cancer
An observational study of Metastatic Gastric Cancer, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Retrospective-prospective observational study in which a novel whole-exome sequencing (WES) approach will be used in association with whole-transcriptome sequencing (WTS) to analyze two independent and equally sized cohorts of patients with mGC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Gastric Cancer
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2021to 10 Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced or metastatic inoperable GC who are candidates for first-line chemotherapy and who meet the following criteria.
Who may be able to join
- Age >18 years;
- Histological diagnosis of locally advanced or metastatic gastric cancer (GC) or gastroesophageal junction carcinoma (EJC);
- Adequate biological material for molecular analysis, collected (at surgery or by biopsy) before the administration of any anti-tumor treatment (chemotherapy and/or radiotherapy);
- ECOG PS 0-2;
- Adequate hematological, hepatic and renal function;
- Measurable disease according to RECIST criteria;
- Written informed consent.
Who cannot join
- Previous chemotherapy for metastatic disease;
- Comorbidities not controlled with adequate medical therapy;
- Brain metastases;
- Patient unable to give adequate consent to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective-prospective observational study in which a novel whole-exome sequencing (WES) approach will be used in association with whole-transcriptome sequencing (WTS) to analyze two independent and equally sized cohorts of patients with mGC.
Read the detailed description
A workflow specifically designed for this project will be adopted, using clinical outcomes as a benchmark for comparative analyses, to generate a molecular classifier applicable to all patients affected by metastatic gastric cancer mGC and predict atypical tumor responses. Molecular features differently represented in exceptional responders and fast progressors will be monitored by liquid biopsy in patients included in cohort B, consisting of a validation set, leveraging a high-sensitivity technological level that allows to detect both genomic alterations and expression at the transcription level.
In addition, CSCs isolated from fast progressors will be studied with over 1,000 antitumor agents to discover vulnerabilities not currently known.
- Conditions
- Metastatic Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective, identification set | A workflow based on numerous statistical analyses will assign the individual molecular outcomes in one of the three categories considered (exceptional responders, conventional responders, fast progressors). The information retrieved with this first level of analysis will be summarized in a single tool for the prediction of individual risk (nomogram). In order to guarantee reproducibility, the prognostic classifier will be obtained from a retrospective cohort of patients with mGC treated with standard first-line chemotherapy. | |
| Prospective, validation set | Definition of the evolutionary trajectories of atypical responders mGC, by taking blood samples from patients enrolled in the prospective cohort, collected at predefined time points. The serial collection of blood samples will allow the study of circulating nucleic acids (cfTNA, liquid biopsy) for the monitoring of genomic alterations and for the levels of gene expression differentially represented in exceptional responders and fast progressors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival PFS
PFS will be defined as the time from the start of first-line chemotherapy to disease progression or death
Measured: 5 years
Secondary outcomes (1)
Overall survival OS
OS will be defined as the time from the start of first-line chemotherapy to death (from any cause)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start10 Jan 2021
- Primary completion20 Jun 2023
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877910
- Sponsor's protocol ID
- RS1377/20(2378)
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Molecular Traits of Non-canonical Responders to Advance Personalized Therapy in Gastric Cancer
- ClinicalTrials.gov ID
- NCT06877910
- Acronym / sponsor ID
- RS1377/20(2378)
- Conditions
- Metastatic Gastric Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 14 Mar 2025 (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.
Retrospective-prospective observational study in which a novel whole-exome sequencing (WES) approach will be used in association with whole-transcriptome sequencing (WTS) to analyze two independent and equally sized cohorts of patients with mGC.
Detailed description
A workflow specifically designed for this project will be adopted, using clinical outcomes as a benchmark for comparative analyses, to generate a molecular classifier applicable to all patients affected by metastatic gastric cancer mGC and predict atypical tumor responses. Molecular features differently represented in exceptional responders and fast progressors will be monitored by liquid biopsy in patients included in cohort B, consisting of a validation set, leveraging a high-sensitivity technological level that allows to detect both genomic alterations and expression at the transcription level.
In addition, CSCs isolated from fast progressors will be studied with over 1,000 antitumor agents to discover vulnerabilities not currently known.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective, identification set | – | –A workflow based on numerous statistical analyses will assign the individual molecular outcomes in one of the three categories considered (exceptional responders, conventional responders, fast progressors). The information retrieved with this first level of analysis will be summarized in a single tool for the prediction of individual risk (nomogram). In order to guarantee reproducibility, the prognostic classifier will be obtained from a retrospective cohort of patients with mGC treated with standard first-line chemotherapy. |
| Prospective, validation set | – | –Definition of the evolutionary trajectories of atypical responders mGC, by taking blood samples from patients enrolled in the prospective cohort, collected at predefined time points. The serial collection of blood samples will allow the study of circulating nucleic acids (cfTNA, liquid biopsy) for the monitoring of genomic alterations and for the levels of gene expression differentially represented in exceptional responders and fast progressors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced or metastatic inoperable GC who are candidates for first-line chemotherapy and who meet the following criteria.
Key inclusion criteria (7 listed)
- Age >18 years;
- Histological diagnosis of locally advanced or metastatic gastric cancer (GC) or gastroesophageal junction carcinoma (EJC);
- Adequate biological material for molecular analysis, collected (at surgery or by biopsy) before the administration of any anti-tumor treatment (chemotherapy and/or radiotherapy);
- ECOG PS 0-2;
- Adequate hematological, hepatic and renal function;
Key exclusion criteria (4 listed)
- Previous chemotherapy for metastatic disease;
- Comorbidities not controlled with adequate medical therapy;
- Brain metastases;
- Patient unable to give adequate consent to the study.
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
Progression-free survival PFS
Time frame: 5 years
PFS will be defined as the time from the start of first-line chemotherapy to disease progression or death
1 secondary outcome
Overall survival OS
Time frame: 5 years
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 14 Mar 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Metastatic Gastric Cancer, run by Regina Elena Cancer Institute 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 7 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: under way, not looking for participants, as of the sponsor's last update on 14 Mar 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival PFS (time frame: 5 years). 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 14 Mar 2025.