- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00963092
Study of Blood and Tissue Samples From Patients With Stomach Cancer, Esophageal Cancer, or Gastroesophageal Junction Cancer
Stomach and Oesophageal Cancer Study (SOCS)
RATIONALE: Collecting and storing samples of tissue, blood, and saliva from patients with cancer to test in the laboratory may help the study of cancer in the future.
PURPOSE: This research study is collecting blood and tissue samples from patients with stomach cancer, esophageal cancer, or gastroesophageal junction cancer, studying them in the laboratory, and storing them for future studies.
Visão geral do estudo
Status
Descrição detalhada
OBJECTIVES:
- To set up a population-based gastric and esophageal cancer cohort with comprehensive epidemiological, clinical, and pathological data in order to identify novel genetic and environmental risk factors for these cancers using an association study design.
- To establish a blood-based epidemiological resource with parallel tumor samples on a population-based series of gastric and esophageal cancer cases.
- Compare any differences in genetic susceptibility genes according to the site of esophago-gastric cancer (e.g., distal gastric, proximal gastric, or junctional and esophageal tumors) and the histopathological sub-type.
- Test existing molecular hypotheses and determine whether common genetic variants in candidate genes predispose to gastric and esophageal cancer by comparing the frequency of variants in cancer patients with that in controls.
- Generate new hypotheses of genetic and certain environmental determinants, explore the potential impact on cancer disease risk of a range of environmental factors that can be measured in plasma (e.g., antibodies to various infective agents, markers of systemic inflammation, markers of oxidation), and examine gene-environment interactions.
- Refine our understanding of risk factors that are identified (e.g.,chronic Helicobacter pylori infection and smoking) and examine how these interact with genetic determinants of disease.
- Define the proportion of gastric cancer incidence attributable to mutations in known predisposing genes, such as E-cadherin.
- Obtain data on molecular profiles of tumors (mostly paraffin-embedded, rarely frozen) using dense array technologies, therefore enabling studies of the interaction between germline polymorphisms and tumor somatic genotype upon tumor behavior, response to treatment, and patient outcome.
OUTLINE: This is a multicenter study.
Patients and healthy controls complete an epidemiological questionnaire, provide a blood sample for plasma and genetic analyses, and may also provide a saliva sample. Tumor samples (in the form of paraffin block material or, in rare cases, frozen) may also be obtained from the hospital where the patient underwent surgery.
White blood cells are assayed for DNA/RNA isolation to look at genetic variants. DNA is extracted from saliva to look at genetic variants. Plasma/serum samples are analyzed to look at proteins and serological markers. Tumor samples are used to review the histology type. Nucleic acids are extracted from tumor sample sections; retrieval of a small (0.6 mm) core from each section is used to construct a tissue microarray which are be analyzed by immunohistochemistry and FISH.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
PROJECTED ACCRUAL: A total of 1,000 patients per cancer (gastric and esophageal) and 2,000 controls will be accrued for this study.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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England
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Cambridge, England, Reino Unido, CB2 0RE
- Recrutamento
- Cancer Research UK at Cambridge Research Institute
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Contato:
- Carlos Caldas
- Número de telefone: 44-1223-404-420
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Must meet 1 of the following criteria:
Diagnosis of gastric or esophageal adenocarcinoma
- Diagnosed within the past 5 years
- May include gastro-esophageal junction tumor
- Spouse or relative of the patient
- Samples collected from the European Prospective Investigation of Cancer (EPIC) study
- Patients will be approached to participate in the study regardless of their current treatment being curative or palliative, medical or surgical, or if they are currently having follow-up clinical appointments
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Plano de estudo
Como o estudo é projetado?
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
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Creation of repository of blood, saliva, and tumor samples
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Carlos Caldas, Cancer Research UK
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- câncer gástrico estágio IV
- câncer gástrico recorrente
- câncer de esôfago estágio II
- câncer de esôfago estágio III
- adenocarcinoma do estômago
- adenocarcinoma de esôfago
- adenocarcinoma da junção gastroesofágica
- câncer de esôfago recorrente
- câncer de esôfago estágio IV
- câncer de esôfago estágio I
- câncer gástrico estágio IIIA
- câncer gástrico estágio IIIB
- câncer gástrico estágio IIIC
- câncer gástrico estágio IA
- câncer gástrico estágio IB
- câncer gástrico estágio IIA
- câncer gástrico estágio IIB
Termos MeSH relevantes adicionais
- Doenças do aparelho digestivo
- Neoplasias por Tipo Histológico
- Neoplasias
- Neoplasias por local
- Carcinoma
- Neoplasias Glandulares e Epiteliais
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças Gastrointestinais
- Doenças do Estômago
- Neoplasias de Cabeça e Pescoço
- Doenças Esofágicas
- Neoplasias do Estômago
- Adenocarcinoma
- Neoplasias Esofágicas
Outros números de identificação do estudo
- CRUK-UC-SOCS-03-5-064
- CDR0000636974 (Identificador de registro: PDQ (Physician Data Query))
- EU-20911
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 .