A Study in Greece Observing How Patients With Stomach and Esophageal Cancer Are Diagnosed and Treated in Everyday Medical Practice (GRACE)
31 de agosto de 2026 actualizado por: AstraZeneca
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
Patients may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the Investigator or AstraZeneca.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.
Tipo de estudio
De observación
Inscripción (Estimado)
300
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: AstraZeneca Clinical Study Information Center
- Número de teléfono: 1 877-240-9479
- Correo electrónico: information.center@astrazeneca.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Distribution of GC/GEJ cancer types
Periodo de tiempo: Measured at baseline, during patients 1st visit.
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Percentage of GC/GEJ cancer types (adenocarcinoma, squamous cell carcinoma, other).
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Measured at baseline, during patients 1st visit.
|
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Clinicopathological characteristics of patients with histologically confirmed stage II to IVB gastric/GEJ cancer.
Periodo de tiempo: 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.
|
Measured at baseline, during patients 1st visit.
|
|
To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.
Periodo de tiempo: 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
|
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
Periodo de tiempo: 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.
|
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)
Periodo de tiempo: 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).
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Up to 18 months ± 30 days (through study completion)
|
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Estimation of key time intervals, measured by time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA)
Periodo de tiempo: 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)
|
Up to 18 months ± 30 days (through study completion)
|
|
Estimation of key time intervals, measured by time (months) from first to second-line.
Periodo de tiempo: 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.
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Up to 18 months ± 30 days (through study completion)
|
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Estimation of key time intervals, measured by time (months) from second-line to third-line systemic treatment (for Stage IVB).
Periodo de tiempo: 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).
|
Up to 18 months ± 30 days (through study completion)
|
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Duration of each systemic treatment line (overall and by type: chemotherapy, targeted therapy/immunotherapy; up to 3rd line)
Periodo de tiempo: 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)
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Up to 18 months ± 30 days (through study completion)
|
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Description of dosing schemes
Periodo de tiempo: 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.
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Up to 18 months ± 30 days (through study completion)
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To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.
Periodo de tiempo: Up to 18 months ± 30 days (through study completion)
|
To describe treatment sequences.
|
Up to 18 months ± 30 days (through study completion)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pathologic complete response (pCR) rate
Periodo de tiempo: Up to 18 months ± 30 days (through study completion)
|
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.
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Up to 18 months ± 30 days (through study completion)
|
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Description of types of biomarkers tested at diagnosis, by disease stage (II-IVA, IVB).
Periodo de tiempo: Up to 18 months ± 30 days (through study completion)
|
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).
|
Up to 18 months ± 30 days (through study completion)
|
|
Percentage of patients tested for biomarkers.
Periodo de tiempo: Up to 18 months ± 30 days (through study completion)
|
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.
|
Up to 18 months ± 30 days (through study completion)
|
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Percentage of positive results by biomarker type.
Periodo de tiempo: Up to 18 months ± 30 days (through study completion)
|
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.
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Up to 18 months ± 30 days (through study completion)
|
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Time from diagnosis to biomarker results captured during biomarkers testing by disease stage (II-IVA, IVB).
Periodo de tiempo: Up to 18 months ± 30 days (through study completion)
|
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.
|
Up to 18 months ± 30 days (through study completion)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de septiembre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
24 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de agosto de 2026
Publicado por primera vez (Actual)
2 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Estómago
- Neoplasias Glandulares y Epiteliales
- Carcinoma
- Neoplasias de Estómago
- Adenocarcinoma
Otros números de identificación del estudio
- D133HR00065
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIPhRMA Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Criterios de acceso compartido de IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .