A Study in Greece Observing How Patients With Stomach and Esophageal Cancer Are Diagnosed and Treated in Everyday Medical Practice
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-130
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: Patients with Stage II-IVB Gastric/GEJ Adenocarcinoma
Trial outcomes
Primary outcomes
1
Distribution of GC/GEJ cancer types
Percentage of GC/GEJ cancer types (adenocarcinoma, squamous cell carcinoma, other).
Time frame
Measured at baseline, during patients 1st visit.2
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.
Time frame
Measured at baseline, during patients 1st visit.3
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
Time frame
Up to 18 months ± 30 days (through study completion)4
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.
Time frame
Up to 18 months ± 30 days (through study completion)Secondary outcomes
1
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.
Time frame
Up to 18 months ± 30 days (through study completion)2
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).
Time frame
Up to 18 months ± 30 days (through study completion)3
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.
Time frame
Up to 18 months ± 30 days (through study completion)4
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.
Time frame
Up to 18 months ± 30 days (through study completion)Sponsors and contacts
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Source ClinicalTrials.gov