Gastric CancerLEGACY-2NCT04015466
Advanced GC Multi-omic Characterization in EU and CELAC Populations
An observational study of Gastric Cancer, run by Fundación para la Investigación del Hospital Clínico de Valencia at 8 sites in 7 countries.
Trial summary
Observational study (cohort type) of advanced GC patients that will be recruited prospectively to study biological factors associated with the disease and relevant clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastric Cancer
- How many people
- 800 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 12 Jun 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- Adult, Older adult
Study population: * Subjects >18 years old, with high diagnostic suspicion of advanced GC diagnosis (Stage III and IV) * Subjects >18 years old to whom a gastroscopy was indicated and confirmed absent of GC.
Who may be able to join
- Subjects ≥18 years old.
- GC diagnosis stages III and IV (including gastroesophageal junction cancer) and/or a gastroscopy indication due to the high diagnostic suspicion of GC as part of the study of his disease.
- Has given and signed the IC to participate in this study.
- Subjects ≥18 years old.
- Subjects to whom a gastroscopy is indicated within clinical care and is confirmed absent of GC in the same centres will be matched in age (+/- 10 years), gender and pertaining from the same region of the GC case.
- Has given and signed the IC to participate in this study.
Who cannot join
- Patients diagnosed with GC early disease (stage I and II) suitable for resectable strategy.
- Withdrawal criteria:
- Patients initially recruited with high suspicion of GC diagnosis but not confirmed by the pathological report.
- Controls:
- Subjects from a different geographic area from the cases.
- Patients with high suspicion of GC.
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- Patients with previous histopathologic diagnosis of peptic (gastric or duodenal) ulcer disease and/or atrophy or intestinal metaplasia.
- Patients that have received antimicrobials during the 4 weeks period prior to the endoscopy.
- Patients that have received proton pump inhibitors or H2-receptor antagonists, at least 2 weeks prior to the endoscopy
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
Spain2 sites
Vall d'Hebron Institut d'Oncologia
Barcelona, 08035
Hospital Clínico Univeristario de Valencia
Valencia, 46010
Portugal1 site
Institute of Pathology and Immunology of University of Porto
Porto, 4200 135
About this study
Observational study (cohort type) of advanced GC patients that will be recruited prospectively to study biological factors associated with the disease and relevant clinical outcomes.
Read the detailed description
Despite of multiple attempts to improve treatment in recent decades, none strategies has improved prognosis in locally advanced stage III and IV GC. A therapeutic approach to GC based on current histological and image criteria (Tumour Node Metastasis -TNM- stage) is insufficient. Although multiple targeted agents are currently under investigation, so far, only trastuzumab and ramucirumab have demonstrated efficacy in advanced GC and have a regulatory approval. For this reason, the identification of specific targets that could be susceptible for drug inhibition, is an urgent requirement. Moreover, most studies and current international databases on late-stage/advanced GC are largely based on Asian populations, in sharp contrast tumour biology and genome of EU or CELAC populations remain poorly known.
The primary objective of this study are to:
- Characterize a multi-centric cohort including EU and CELAC populations diagnosed with advanced GC through a multi-omic approach including proteomics, genomics, transcriptomics, microbiome and exposome analysis due to study the determinants of GC.
- Identify the regional differences in EU and CELAC populations recruiting patients for this study for each omic characterization due to identify the high-risk group populations.
- Identify and select from the multi-omic approach those biomarkers useful for the development of an algorithm to guide the therapeutic approach for advanced GC.
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Personalized medicine, Oncology, Solid tumor, Primary Intervention
- Medical subject headings
- Stomach Neoplasms, 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 |
|---|---|---|
| Cases | Patients with high diagnostic suspicion of advanced GC diagnosis | |
| Control | Patients with confirmed absent of GC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a new diagnostic algorithm for gastric cancer that includes molecular landscape, patient history, histopathological and environmental factors, personal microbiome and immune landscape
The project will look for an integrative diagnostic algorithm that incorporates multi-parameter inputs and apply artificial intelligence to provide more personalized risk estimates and which will form the basis for future development of a clinical tool
Measured: 3 years
Secondary outcomes (7)
Proteomic analysis of gastric cancer tissue
Determine the expression of certain proteins using ICH and ISH
Measured: 3 years
Genomics (tumour next-generation sequencing)
Determine differences in the genetic mutational profile of different populations
Measured: 3 years
Transcriptomics (Nanostring immune gene expression panel)
Determine differences in the genetic expression profile of different populations
Measured: 3 years
Microbiota sequencing (including level of Epstein-Barr virus [EBV] DNA)
Determine differences in the microbiota profile of different populations
Measured: 3 years
Dietary habits as assessed by a new study-specific questionnaire
Determine differences in dietary habits of different populations and its correlation with risk to develop gastric cancer
Measured: 3 years
Biological risk factors as assessed through medical chart review
Determine differences in biological risk factors of different populations and its correlation with risk to develop gastric cancer
Measured: 3 years
Daily routines as assessed by a new study-specific questionnaire
Determine differences daily routines of different populations and its correlation with risk to develop gastric cancer
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start12 Jun 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Cancerologia de Mexico, Amsterdam UMC, location VUmc, Pontificia Universidad Catolica de Chile, Vall d'Hebron Institute of Oncology, INSTITUTO ALEXANDER FLEMING, Hospital Central del IPS, IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015466
- Sponsor's protocol ID
- LEGACY-2
- Acronym
- LEGACY-2
- Status last verified
- May 2024
- First submitted
- 5 Jun 2019
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Schooten TS, Derks S, Jimenez-Marti E, Carneiro F, Figueiredo C, Ruiz E, Alsina M, Molero C, Garrido M, Riquelme A, Caballero C, Lezcano E, O'Connor JM, Esteso F, Farres J, Mas JM, Lordick F, Vogt J, Cardone A, Girvalaki C, Cervantes A, Fleitas T; members of LEGACy consortium. The LEGACy study: a European and Latin American consortium to identify risk factors and molecular phenotypes in gastric cancer to improve prevention strategies and personalized clinical decision making globally. BMC Cancer. 2022 Jun 13;22(1):646. doi: 10.1186/s12885-022-09689-9.
PubMed 35692051
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced GC Multi-omic Characterization in EU and CELAC Populations
- ClinicalTrials.gov ID
- NCT04015466
- Acronym / sponsor ID
- LEGACY-2 / LEGACY-2
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Personalized medicine, Oncology, Solid tumor, Primary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Collaborators
- Instituto Nacional de Cancerologia de Mexico, Amsterdam UMC, location VUmc, Pontificia Universidad Catolica de Chile, Vall d'Hebron Institute of Oncology, INSTITUTO ALEXANDER FLEMING, Hospital Central del IPS, IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Jul 2019 (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.
Observational study (cohort type) of advanced GC patients that will be recruited prospectively to study biological factors associated with the disease and relevant clinical outcomes.
Detailed description
Despite of multiple attempts to improve treatment in recent decades, none strategies has improved prognosis in locally advanced stage III and IV GC. A therapeutic approach to GC based on current histological and image criteria (Tumour Node Metastasis -TNM- stage) is insufficient. Although multiple targeted agents are currently under investigation, so far, only trastuzumab and ramucirumab have demonstrated efficacy in advanced GC and have a regulatory approval. For this reason, the identification of specific targets that could be susceptible for drug inhibition, is an urgent requirement. Moreover, most studies and current international databases on late-stage/advanced GC are largely based on Asian populations, in sharp contrast tumour biology and genome of EU or CELAC populations remain poorly known.
The primary objective of this study are to:
- Characterize a multi-centric cohort including EU and CELAC populations diagnosed with advanced GC through a multi-omic approach including proteomics, genomics, transcriptomics, microbiome and exposome analysis due to study the determinants of GC.
- Identify the regional differences in EU and CELAC populations recruiting patients for this study for each omic characterization due to identify the high-risk group populations.
- Identify and select from the multi-omic approach those biomarkers useful for the development of an algorithm to guide the therapeutic approach for advanced GC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Patients with high diagnostic suspicion of advanced GC diagnosis |
| Control | – | –Patients with confirmed absent of GC |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Subjects >18 years old, with high diagnostic suspicion of advanced GC diagnosis (Stage III and IV) * Subjects >18 years old to whom a gastroscopy was indicated and confirmed absent of GC.
Key inclusion criteria (6 listed)
Key exclusion criteria (9 listed)
- Withdrawal criteria:
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
Development of a new diagnostic algorithm for gastric cancer that includes molecular landscape, patient history, histopathological and environmental factors, personal microbiome and immune landscape
Time frame: 3 years
The project will look for an integrative diagnostic algorithm that incorporates multi-parameter inputs and apply artificial intelligence to provide more personalized risk estimates and which will form the basis for future development of a clinical tool
7 secondary outcomes
Proteomic analysis of gastric cancer tissue
Time frame: 3 years
Genomics (tumour next-generation sequencing)
Time frame: 3 years
Transcriptomics (Nanostring immune gene expression panel)
Time frame: 3 years
Microbiota sequencing (including level of Epstein-Barr virus [EBV] DNA)
Time frame: 3 years
Dietary habits as assessed by a new study-specific questionnaire
Time frame: 3 years
Biological risk factors as assessed through medical chart review
Time frame: 3 years
Daily routines as assessed by a new study-specific questionnaire
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 35692051van Schooten TS, Derks S, Jimenez-Marti E, Carneiro F, Figueiredo C, Ruiz E, Alsina M, Molero C, Garrido M, Riquelme A, Caballero C, Lezcano E, O'Connor JM, Esteso F, Farres J, Mas JM, Lordick F, Vogt J, Cardone A, Girvalaki C, Cervantes A, Fleitas T; members of LEGACy consortium. The LEGACy study: a European and Latin American consortium to identify risk factors and molecular phenotypes in gastric cancer to improve prevention strategies and personalized clinical decision making globally. BMC Cancer. 2022 Jun 13;22(1):646. doi: 10.1186/s12885-022-09689-9.
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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.
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Fundación para la Investigación del Hospital Clínico de Valencia at 8 sites in 7 countries.
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 9 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: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Argentina, Chile, Mexico, Netherlands and 2 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Development of a new diagnostic algorithm for gastric cancer that includes molecular landscape, patient history, histopathological and environmental factors, personal microbiome and immune landscape (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04015466, which also lists 1 linked publication.
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 9 May 2024.