Clinical trial NCT00963092: Study of Blood and Tissue Samples From Patients With Stomach Cancer, Esophageal Cancer, or Gastroesophageal Junction Cancer
Official title: Stomach and Oesophageal Cancer Study (SOCS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Gastric Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-08-21
Enrollment: 4000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Creation of repository of blood, saliva, and tumor samples
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cancer Research UK at Cambridge Research Institute
state: England
Study officials:
affiliation: Cancer Research UK
name: Carlos Caldas
role: PRINCIPAL_INVESTIGATOR
References: