- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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England
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Cambridge, England, Regno Unito, CB2 0RE
- Reclutamento
- Cancer Research UK at Cambridge Research Institute
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Contatto:
- Carlos Caldas
- Numero di telefono: 44-1223-404-420
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Creation of repository of blood, saliva, and tumor samples
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Carlos Caldas, Cancer Research UK
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- carcinoma gastrico in stadio IV
- carcinoma gastrico ricorrente
- carcinoma esofageo in stadio II
- carcinoma esofageo in stadio III
- adenocarcinoma dello stomaco
- adenocarcinoma dell'esofago
- adenocarcinoma della giunzione gastroesofagea
- carcinoma esofageo ricorrente
- carcinoma esofageo in stadio IV
- carcinoma esofageo in stadio I
- carcinoma gastrico in stadio IIIA
- carcinoma gastrico in stadio IIIB
- carcinoma gastrico in stadio IIIC
- carcinoma gastrico in stadio IA
- carcinoma gastrico in stadio IB
- carcinoma gastrico in stadio IIA
- carcinoma gastrico in stadio IIB
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie per sede
- Carcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie gastrointestinali
- Malattie dello stomaco
- Neoplasie della testa e del collo
- Malattie esofagee
- Neoplasie allo stomaco
- Adenocarcinoma
- Neoplasie esofagee
Altri numeri di identificazione dello studio
- CRUK-UC-SOCS-03-5-064
- CDR0000636974 (Identificatore di registro: PDQ (Physician Data Query))
- EU-20911
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .