Gastric CancerGRAMMYNCT04842916
InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer
An observational study of Gastric Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 5 sites in 3 countries.
Trial summary
Multicentric, exploratory, non-pharmacologic, retrospective/prospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response to chemotherapy in gastric cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastric Cancer
- How many people
- 250 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 22 Sep 2020to 22 May 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with potentially resectable adenocarcinoma of the stomach (GC) or the gastric-esophageal junction (GEJ) who received pre- or peri-operative chemotherapy or up-front surgery followed by chemotherapy
Who may be able to join
- Patients with diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach (GC) or the gastric-esophageal junction (GEJ) treated with the standard regimens (5-Fluoro-Uracil or Capecitabine + Oxaliplatin +/- Docetaxel)
- Participant is willing and able to give informed consent for participation in the study (prospective and retrospective cohort) or Substitutive Informed Consent Declaration Form will be subscribed by the PI for patients that are not reachable
- Male or Female, aged >18 years
- Availability of tissue samples and clinico-pathological data for retrospective cohort
Who cannot join
- Age < 18 years
- Early Gastric Cancer and T2 (if N0)
- Linitis plastica
- Positive peritoneal cytology or peritoneal involvement
- Distant metastases
- Patient refusal to participate
Show all 10Show fewer
- Patient refusal to the use of their own samples for research
- Patient withdrawing from treatment plan whilst under therapy due to patient co-morbidities or failure to comply with clinical counselling
- Patients with underlying pathologies rendering sampling of biological material either as endangering patient's clinical status or as unusable
- Patients with mental illness hindering the capacity to provide precise information in questionnaires or successfully comply with caregiver's recommendations
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Chiara Molinari contact
Chiara Zingaretti contact
5 sites in 3 countries
France2 sites, 1 recruiting
- Not yet recruiting
Centre Hospitalier Regional et Universitaire (CHRU)
Brest, 29200
Jean-Philippe Metges
- Active, not recruiting
INSERM, Faculty of Medicine (UMR1078)
Brest, 29200
Italy2 sites, 1 recruiting
- Recruiting
IRST IRCCS UO Oncologia
Meldola, 47014
Manlio Monti
- Active, not recruiting
AUSL Romagna, UO Oncologia
Ravenna, 48121
Greece1 site, 1 recruiting
- Not yet recruiting
1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA)
Athens, 11527
Manousos Konstandoulakis
About this study
Multicentric, exploratory, non-pharmacologic, retrospective/prospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response to chemotherapy in gastric cancer patients.
Read the detailed description
Gastric cancer (GC) is a complex disease that represents the fifth most common malignancy in the world and the third leading cause of cancer death in both sexes. Chemotherapy (CT) combined with surgery represents the standard of care for stages II-III GC, but the efficacy of such treatments is still limited for many patients. It is mandatory to develop novel strategies aimed at identifying predictive markers, as well as deciphering the impact of the psychological-social and cultural environment of each patient on the outcome. GRAMMY study proposes a novel interdisciplinary approach integrating high impact basic, translational and psychological/sociological research towards developing an optimized patient stratification tool for the early prediction of therapy-resistant GC patient groups.
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Chemotherapy, Response, Personalized medicine
- 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 |
|---|---|---|
| Gastric cancer patients | gastric cancer patients with histologically confirmed, potentially resectable adenocarcinoma of the stomach or the gastroesophageal junction receiving the standard of medical care in Europe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic alterations in tumoral tissue in responders and non-responders
Number of Genomic alterations in tumoral tissue
Measured: 36 months
Quantitative and qualitative analysis of the tumor microenvironment composition in responders and non-responders
Analysis of type and size of immune cell subpopulations surrounding primary tumor and extracellular matrix composition on FFPE samples collected at diagnosis and/or surgery. Correlation of data acquired to Participant's response score (TRG or DFS).
Measured: 36 months
Analysis of cell-free DNA (cfDNA) from blood samples in responders and non-responders
cfDNA will be quantified in Participant's peripheral blood derivatives (plasma, serum) and characterized for Genomic alterations. Samples will be obtained (1) prior to and (2) by completion of chemotherapy in the Neoadjuvant Chemotherapy (NCT) treated cohorts, together with sampling after surgery (3). TRG score will be utilized as measure of response. Accordingly, in NCT-naive cohorts, analysis of samples obtained 1) pre- operatively and 2) by completion of post-operative chemotherapy treatment will be correlated with the respective Disease-Progression clinical indicators.
Measured: 36 months
Analysis of circulating tumor cells (CTC) from blood samples in responders and non-responders.
gene expression profile of CTC cells (when isolated in sufficient quantity)
Measured: 36 months
Peripheral blood mononuclear cells (PBMCs) and host immunity parameters in responders and non-responders
Phenotype analysis of representative immune cell subpopulations (i.e. monocytes, helper T cells, cytotoxic T cells, Tregs, Natural Killer (NK) /NKT) in Participants' peripheral blood samples obtained prior- and post- treatment. Combinational analysis of data acquired in correlation with Patient's response score.
Measured: 36 months
Secondary outcomes (1)
Psychological status of patients in relation to therapy response
Psychological status of patients in relation to therapy response evaluated by a psychologist through structured interview
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 posted13 Apr 2021
- Study start22 Sep 2020
- Primary completion22 May 2027 (estimated)
- Study completion22 May 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
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- ERA PERMED
- Responsible party
- Sponsor
- Investigators
- Chiara Molinari, Study chair, IRST IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842916
- Sponsor's protocol ID
- IRSTB111
- Acronym
- GRAMMY
- Status last verified
- Nov 2024
- First submitted
- 23 Dec 2020
- Last updated
- 21 Nov 2024
- 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer
- ClinicalTrials.gov ID
- NCT04842916
- Acronym / sponsor ID
- GRAMMY / IRSTB111
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Chemotherapy, Response, Personalized medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Collaborators
- ERA PERMED
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 22 May 2027 (estimated)
- Study completion
- 22 May 2027 (estimated)
- First posted
- 13 Apr 2021 (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.
Multicentric, exploratory, non-pharmacologic, retrospective/prospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response to chemotherapy in gastric cancer patients.
Detailed description
Gastric cancer (GC) is a complex disease that represents the fifth most common malignancy in the world and the third leading cause of cancer death in both sexes. Chemotherapy (CT) combined with surgery represents the standard of care for stages II-III GC, but the efficacy of such treatments is still limited for many patients. It is mandatory to develop novel strategies aimed at identifying predictive markers, as well as deciphering the impact of the psychological-social and cultural environment of each patient on the outcome. GRAMMY study proposes a novel interdisciplinary approach integrating high impact basic, translational and psychological/sociological research towards developing an optimized patient stratification tool for the early prediction of therapy-resistant GC patient groups.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer patients | – | –gastric cancer patients with histologically confirmed, potentially resectable adenocarcinoma of the stomach or the gastroesophageal junction receiving the standard of medical care in Europe |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with potentially resectable adenocarcinoma of the stomach (GC) or the gastric-esophageal junction (GEJ) who received pre- or peri-operative chemotherapy or up-front surgery followed by chemotherapy
Key inclusion criteria (4 listed)
- Patients with diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach (GC) or the gastric-esophageal junction (GEJ) treated with the standard regimens (5-Fluoro-Uracil or Capecitabine + Oxaliplatin +/- Docetaxel)
- Participant is willing and able to give informed consent for participation in the study (prospective and retrospective cohort) or Substitutive Informed Consent Declaration Form will be subscribed by the PI for patients that are not reachable
- Male or Female, aged >18 years
- Availability of tissue samples and clinico-pathological data for retrospective cohort
Key exclusion criteria (10 listed)
- Age < 18 years
- Early Gastric Cancer and T2 (if N0)
- Linitis plastica
- Positive peritoneal cytology or peritoneal involvement
- Distant metastases
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
Genomic alterations in tumoral tissue in responders and non-responders
Time frame: 36 months
Number of Genomic alterations in tumoral tissue
Quantitative and qualitative analysis of the tumor microenvironment composition in responders and non-responders
Time frame: 36 months
Analysis of type and size of immune cell subpopulations surrounding primary tumor and extracellular matrix composition on FFPE samples collected at diagnosis and/or surgery. Correlation of data acquired to Participant's response score (TRG or DFS).
Analysis of cell-free DNA (cfDNA) from blood samples in responders and non-responders
Time frame: 36 months
cfDNA will be quantified in Participant's peripheral blood derivatives (plasma, serum) and characterized for Genomic alterations. Samples will be obtained (1) prior to and (2) by completion of chemotherapy in the Neoadjuvant Chemotherapy (NCT) treated cohorts, together with sampling after surgery (3). TRG score will be utilized as measure of response. Accordingly, in NCT-naive cohorts, analysis of samples obtained 1) pre- operatively and 2) by completion of post-operative chemotherapy treatment will be correlated with the respective Disease-Progression clinical indicators.
Analysis of circulating tumor cells (CTC) from blood samples in responders and non-responders.
Time frame: 36 months
gene expression profile of CTC cells (when isolated in sufficient quantity)
Peripheral blood mononuclear cells (PBMCs) and host immunity parameters in responders and non-responders
Time frame: 36 months
Phenotype analysis of representative immune cell subpopulations (i.e. monocytes, helper T cells, cytotoxic T cells, Tregs, Natural Killer (NK) /NKT) in Participants' peripheral blood samples obtained prior- and post- treatment. Combinational analysis of data acquired in correlation with Patient's response score.
1 secondary outcome
Psychological status of patients in relation to therapy 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 21 Nov 2024.
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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.
Chiara Molinari contact
Chiara Zingaretti contact
Chiara Molinari study chair
IRST IRCCS
5 sites in 3 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 Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 5 sites in 3 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 4 inclusion and 10 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Italy, Greece. 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 Chiara Molinari (chiara.molinari@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic alterations in tumoral tissue in responders and non-responders (time frame: 36 months). The study lists 5 primary outcomes in all. 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 21 Nov 2024.