Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00963092
First received: August 20, 2009
Last updated: August 29, 2009
Last verified: August 2009
History of Changes

August 20, 2009
August 29, 2009
August 2002
December 2010   (final data collection date for primary outcome measure)
Creation of repository of blood, saliva, and tumor samples [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00963092 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.
Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
Not Provided
December 2010   (final data collection date for primary outcome measure)

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
Both
16 Years and older
Yes
Not Provided
United Kingdom
 
NCT00963092
CDR0000636974, CRUK-UC-SOCS-03/5/064, EU-20911
Not Provided
Not Provided
Cancer Research UK at Cambridge Research Institute
Not Provided
Principal Investigator: Carlos Caldas Cancer Research UK at Cambridge Research Institute
National Cancer Institute (NCI)
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP