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 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Descrição detalhada
Patients may withdraw from the study at any time at their own request, or they may be withdrawn at any time at the discretion of the Investigator or AstraZeneca.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 estudo
Observacional
Inscrição (Estimado)
300
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: AstraZeneca Clinical Study Information Center
- Número de telefone: 1 877-240-9479
- E-mail: information.center@astrazeneca.com
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Distribution of GC/GEJ cancer types
Prazo: 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.
Prazo: Measured at baseline, during patients 1st visit.
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Patient and disease characteristics at diagnosis for patients with histologically confirmed stage II to IVB GC/GEJ adenocarcinoma.
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Measured at baseline, during patients 1st visit.
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To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.
Prazo: Up to 18 months ± 30 days (through study completion)
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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
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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, measured as frequencies per stage
Prazo: Up to 18 months ± 30 days (through study completion)
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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.
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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 diagnosis to neoadjuvant or perioperative treatment and/or surgery (if applicable)
Prazo: 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 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)
Prazo: 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 by estimation of key time intervals, including time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA)
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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 first to second-line.
Prazo: 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).
Prazo: 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 by estimating key time intervals, including time (months) from second-line to third-line systemic treatment (for Stage IVB).
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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)
Prazo: 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 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
Prazo: 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 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.
Prazo: Up to 18 months ± 30 days (through study completion)
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To describe treatment sequences.
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Up to 18 months ± 30 days (through study completion)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pathologic complete response (pCR) rate
Prazo: Up to 18 months ± 30 days (through study completion)
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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).
Prazo: Up to 18 months ± 30 days (through study completion)
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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).
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Up to 18 months ± 30 days (through study completion)
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Percentage of patients tested for biomarkers.
Prazo: Up to 18 months ± 30 days (through study completion)
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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.
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Up to 18 months ± 30 days (through study completion)
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Percentage of positive results by biomarker type.
Prazo: Up to 18 months ± 30 days (through study completion)
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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).
Prazo: Up to 18 months ± 30 days (through study completion)
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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.
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Up to 18 months ± 30 days (through study completion)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
30 de setembro de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
24 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de agosto de 2026
Primeira postagem (Real)
2 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de agosto de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D133HR00065
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .