Gastric CancerGRACENCT07800754
A Study in Greece Observing How Patients With Stomach and Esophageal Cancer Are Diagnosed and Treated in Everyday Medical Practice
An observational study of Gastric Cancer and Gastroesophageal Junction Cancer, run by AstraZeneca at 8 sites in Greece.
Trial summary
This is a retrospective-prospective observational, multicenter, single-country study aiming to describe the epidemiological characteristics and management strategies in patients with stage II-IVB gastric/GEJ adenocarcinoma in routine clinical practice in Greece. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- How many people
- 300 participants
- Where
- 8 sitesGreece
- Study dates
- 30 Sep 2026to 31 Dec 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 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 300 adult patients with histologically confirmed, stage II to IVB gastric/GEJ adenocarcinoma will be enrolled from 10-15 oncology clinics of large public and private hospitals, covering diverse geographic areas, in Greece.
Who may be able to join
- Patients aged ≥18 years upon gastric/GEJ adenocarcinoma diagnosis.
- Written signed and dated informed consent by the patient (or their legally acceptable representative, as applicable). For deceased patients on the date of study entry a waiver of consent must be approved by the Hospital EC/IRB.
- Patients diagnosed with histologically confirmed, stage II to IVB adenocarcinoma of gastric/GEJ, between June 1st, 2025 and the end of the recruitment period (Q3 2027).
Who cannot join
- Patients who participate or participated during the data collection period (prospective and retrospective) in any clinical investigation/clinical trial that includes interventions that fall outside the everyday clinical practice.
- Patients who have participated in the design and/or the conduct of the study.
- Patients with another primary malignancy within the last 5 years, for which systemic anticancer treatment is required after the diagnosis of gastric/GEJ cancer.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
8 sites in 1 country
Greece8 sites, 7 recruiting
- Not yet recruiting
Research Site
Alexandroupoli
- Recruiting
Research Site
Athens
- Not yet recruiting
Research Site
Athens
- Withdrawn
Research Site
Athens
- Not yet recruiting
Research Site
Crete
- Not yet recruiting
Research Site
Ioannina
- Not yet recruiting
Research Site
Pátrai
- Not yet recruiting
Research Site
Thessaloniki
About this study
Official title: Epidemiological Characteristics And Management Strategies Of Gastric/Gastrophaegal Junction Cancer Patients In Routine Clinical Practice: A Greek Multicenter Observational Study (The GRACE Study)
This is a retrospective-prospective observational, multicenter, single-country study aiming to describe the epidemiological characteristics and management strategies in patients with stage II-IVB gastric/GEJ adenocarcinoma in routine clinical practice in Greece.
Read the detailed description
Patients may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the Investigator or AstraZeneca. In all cases, every reasonable effort should be made to document patient outcome, if applicable.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Keywords
- Gastric Cancer, Gastroesophageal Junction Cancer, Adenocarcinoma, Observational Study, Real-World Evidence, Epidemiology, Treatment Patterns, Greece
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma
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 |
|---|---|---|
| Patients with Stage II-IVB Gastric/GEJ Adenocarcinoma | Adult patients with histologically confirmed, stage II to IVB gastric/GEJ adenocarcinoma will be enrolled from 10-15 oncology clinics of large public and private hospitals, covering diverse geographic areas, in Greece. Eligible patients will have been diagnosed between June 1st, 2025 and the end of the recruitment period (Q3 2027). The study includes both retrospective and prospective components. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of GC/GEJ cancer types
Percentage of GC/GEJ cancer types (adenocarcinoma, squamous cell carcinoma, other).
Measured: Measured at baseline, during patients 1st visit.
Clinicopathological characteristics of patients with histologically confirmed stage II to IVB gastric/GEJ cancer.
Patient and disease characteristics at diagnosis for patients with histologically confirmed stage II to IVB GC/GEJ adenocarcinoma.
Measured: Measured at baseline, during patients 1st visit.
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.
To describe current treatment modalities (surgery, systemic therapy, radiotherapy, chemoradiation (CRT) and palliative care) applied in the resectable (Stages II-IVA) and advanced/metastatic (Stage IVB) settings, presented as types
Measured: Up to 18 months ± 30 days (through study completion)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma, measured as frequencies per stage
To describe current treatment modalities (surgery, systemic therapy, radiotherapy, chemoradiation (CRT) and palliative care) applied in the resectable (Stages II-IVA) and advanced/metastatic (Stage IVB) settings, presented as frequencies per stage.
Measured: Up to 18 months ± 30 days (through study completion)
Estimation of key time intervals, measured by time (months) from diagnosis to neoadjuvant or perioperative treatment and/or surgery (if applicable)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating key time intervals, including time (months) from diagnosis to neoadjuvant or perioperative treatment and/or surgery (if applicable).
Measured: Up to 18 months ± 30 days (through study completion)
Estimation of key time intervals, measured by time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimation of key time intervals, including time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA)
Measured: Up to 18 months ± 30 days (through study completion)
Estimation of key time intervals, measured by time (months) from first to second-line.
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating key time intervals, including time (months) from first to second-line.
Measured: Up to 18 months ± 30 days (through study completion)
Estimation of key time intervals, measured by time (months) from second-line to third-line systemic treatment (for Stage IVB).
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating key time intervals, including time (months) from second-line to third-line systemic treatment (for Stage IVB).
Measured: Up to 18 months ± 30 days (through study completion)
Duration of each systemic treatment line (overall and by type: chemotherapy, targeted therapy/immunotherapy; up to 3rd line)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating the duration of each systemic treatment line (overall and by type: chemotherapy, targeted therapy/immunotherapy; up to 3rd line)
Measured: Up to 18 months ± 30 days (through study completion)
Description of dosing schemes
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by describing dosing schemes.
Measured: Up to 18 months ± 30 days (through study completion)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.
To describe treatment sequences.
Measured: Up to 18 months ± 30 days (through study completion)
Secondary outcomes (5)
Pathologic complete response (pCR) rate
The proportion of patients with stage II-IVA gastric/GEJ adenocarcinoma with no viable tumor cells, including lymph nodes, in the resected gastric specimen after completion of neoadjuvant therapy and surgery.
Measured: Up to 18 months ± 30 days (through study completion)
Description of types of biomarkers tested at diagnosis, by disease stage (II-IVA, IVB).
To evaluate current biomarker testing strategies and patterns among patients with stage II to IVB gastric/GEJ adenocarcinoma, based on information about types of biomarkers tested at diagnosis, by disease stage (II-IVA, IVB).
Measured: Up to 18 months ± 30 days (through study completion)
Percentage of patients tested for biomarkers.
To evaluate current biomarker testing strategies and patterns among patients with stage II to IVB gastric/GEJ adenocarcinoma, based on percentage of patients tested for biomarkers.
Measured: Up to 18 months ± 30 days (through study completion)
Percentage of positive results by biomarker type.
To evaluate current biomarker testing strategies and patterns among patients with stage II to IVB gastric/GEJ adenocarcinoma, based on percentage of positive results by biomarker type.
Measured: Up to 18 months ± 30 days (through study completion)
Time from diagnosis to biomarker results captured during biomarkers testing by disease stage (II-IVA, IVB).
To evaluate current biomarker testing strategies and patterns among patients with stage II to IVB gastric/GEJ adenocarcinoma, based on information on biomarkers testing by disease stage (II-IVA, IVB), including time from diagnosis to biomarker results.
Measured: Up to 18 months ± 30 days (through study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start30 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800754
- Sponsor's protocol ID
- D133HR00065
- Acronym
- GRACE
- Status last verified
- Jul 2026
- First submitted
- 24 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Characteristics And Management Strategies Of Gastric/Gastrophaegal Junction Cancer Patients In Routine Clinical Practice: A Greek Multicenter Observational Study (The GRACE Study)
- ClinicalTrials.gov ID
- NCT07800754
- Acronym / sponsor ID
- GRACE / D133HR00065
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Keywords
- Gastric Cancer, Gastroesophageal Junction Cancer, Adenocarcinoma, Observational Study, Real-World Evidence, Epidemiology, Treatment Patterns, Greece
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Sep 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.
This is a retrospective-prospective observational, multicenter, single-country study aiming to describe the epidemiological characteristics and management strategies in patients with stage II-IVB gastric/GEJ adenocarcinoma in routine clinical practice in Greece.
Detailed description
Patients may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the Investigator or AstraZeneca. In all cases, every reasonable effort should be made to document patient outcome, if applicable.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Stage II-IVB Gastric/GEJ Adenocarcinoma | – | –Adult patients with histologically confirmed, stage II to IVB gastric/GEJ adenocarcinoma will be enrolled from 10-15 oncology clinics of large public and private hospitals, covering diverse geographic areas, in Greece. Eligible patients will have been diagnosed between June 1st, 2025 and the end of the recruitment period (Q3 2027). The study includes both retrospective and prospective components. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 300 adult patients with histologically confirmed, stage II to IVB gastric/GEJ adenocarcinoma will be enrolled from 10-15 oncology clinics of large public and private hospitals, covering diverse geographic areas, in Greece.
Key inclusion criteria (3 listed)
- Patients aged ≥18 years upon gastric/GEJ adenocarcinoma diagnosis.
- Written signed and dated informed consent by the patient (or their legally acceptable representative, as applicable). For deceased patients on the date of study entry a waiver of consent must be approved by the Hospital EC/IRB.
- Patients diagnosed with histologically confirmed, stage II to IVB adenocarcinoma of gastric/GEJ, between June 1st, 2025 and the end of the recruitment period (Q3 2027).
Key exclusion criteria (3 listed)
- Patients who participate or participated during the data collection period (prospective and retrospective) in any clinical investigation/clinical trial that includes interventions that fall outside the everyday clinical practice.
- Patients who have participated in the design and/or the conduct of the study.
- Patients with another primary malignancy within the last 5 years, for which systemic anticancer treatment is required after the diagnosis of gastric/GEJ cancer.
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
Distribution of GC/GEJ cancer types
Time frame: Measured at baseline, during patients 1st visit.
Percentage of GC/GEJ cancer types (adenocarcinoma, squamous cell carcinoma, other).
Clinicopathological characteristics of patients with histologically confirmed stage II to IVB gastric/GEJ cancer.
Time frame: Measured at baseline, during patients 1st visit.
Patient and disease characteristics at diagnosis for patients with histologically confirmed stage II to IVB GC/GEJ adenocarcinoma.
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.
Time frame: Up to 18 months ± 30 days (through study completion)
To describe current treatment modalities (surgery, systemic therapy, radiotherapy, chemoradiation (CRT) and palliative care) applied in the resectable (Stages II-IVA) and advanced/metastatic (Stage IVB) settings, presented as types
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma, measured as frequencies per stage
Time frame: Up to 18 months ± 30 days (through study completion)
To describe current treatment modalities (surgery, systemic therapy, radiotherapy, chemoradiation (CRT) and palliative care) applied in the resectable (Stages II-IVA) and advanced/metastatic (Stage IVB) settings, presented as frequencies per stage.
Estimation of key time intervals, measured by time (months) from diagnosis to neoadjuvant or perioperative treatment and/or surgery (if applicable)
Time frame: Up to 18 months ± 30 days (through study completion)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating key time intervals, including time (months) from diagnosis to neoadjuvant or perioperative treatment and/or surgery (if applicable).
Estimation of key time intervals, measured by time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA)
Time frame: Up to 18 months ± 30 days (through study completion)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimation of key time intervals, including time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA)
Estimation of key time intervals, measured by time (months) from first to second-line.
Time frame: Up to 18 months ± 30 days (through study completion)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating key time intervals, including time (months) from first to second-line.
Estimation of key time intervals, measured by time (months) from second-line to third-line systemic treatment (for Stage IVB).
Time frame: Up to 18 months ± 30 days (through study completion)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating key time intervals, including time (months) from second-line to third-line systemic treatment (for Stage IVB).
Duration of each systemic treatment line (overall and by type: chemotherapy, targeted therapy/immunotherapy; up to 3rd line)
Time frame: Up to 18 months ± 30 days (through study completion)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by estimating the duration of each systemic treatment line (overall and by type: chemotherapy, targeted therapy/immunotherapy; up to 3rd line)
Description of dosing schemes
Time frame: Up to 18 months ± 30 days (through study completion)
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma by describing dosing schemes.
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.
Time frame: Up to 18 months ± 30 days (through study completion)
To describe treatment sequences.
5 secondary outcomes
Pathologic complete response (pCR) rate
Time frame: Up to 18 months ± 30 days (through study completion)
Description of types of biomarkers tested at diagnosis, by disease stage (II-IVA, IVB).
Time frame: Up to 18 months ± 30 days (through study completion)
Percentage of patients tested for biomarkers.
Time frame: Up to 18 months ± 30 days (through study completion)
Percentage of positive results by biomarker type.
Time frame: Up to 18 months ± 30 days (through study completion)
Time from diagnosis to biomarker results captured during biomarkers testing by disease stage (II-IVA, IVB).
Time frame: Up to 18 months ± 30 days (through study completion)
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 8 Oct 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
AstraZeneca Clinical Study Information Center contact
8 sites 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 and Gastroesophageal Junction Cancer, run by AstraZeneca at 8 sites in Greece.
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 3 inclusion and 3 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 8 Oct 2026. 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 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 AstraZeneca Clinical Study Information Center (877-240-9479 ext. 1, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of GC/GEJ cancer types (time frame: Measured at baseline, during patients 1st visit.). The study lists 11 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 8 Oct 2026.