Study of Blood and Tissue Samples From Patients With Stomach Cancer, Esophageal Cancer, or Gastroesophageal Junction Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00963092
Recruitment Status : Unknown
Verified July 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : August 21, 2009
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment
Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer Gastric Cancer Genetic: DNA analysis Genetic: RNA analysis Genetic: microarray analysis Genetic: protein analysis Other: cytology specimen collection procedure Other: laboratory biomarker analysis Other: questionnaire administration

Detailed Description:


  • 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.

Study Type : Observational
Estimated Enrollment : 4000 participants
Official Title: Stomach and Oesophageal Cancer Study (SOCS)
Study Start Date : August 2002
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Creation of repository of blood, saliva, and tumor samples

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • 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


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00963092

United Kingdom
Cancer Research UK at Cambridge Research Institute Recruiting
Cambridge, England, United Kingdom, CB2 0RE
Contact: Carlos Caldas    44-1223-404-420      
Sponsors and Collaborators
Cancer Research UK
Principal Investigator: Carlos Caldas Cancer Research UK Identifier: NCT00963092     History of Changes
Other Study ID Numbers: CRUK-UC-SOCS-03-5-064
CDR0000636974 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: July 2011

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the gastroesophageal junction
recurrent gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus
recurrent esophageal cancer
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
stage IA gastric cancer
stage IB gastric cancer
stage IIA gastric cancer
stage IIB gastric cancer
stage IIIA gastric cancer
stage IIIB gastric cancer
stage IIIC gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases