search
Back to results

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

Primary Purpose

Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer

Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
DNA analysis
RNA analysis
microarray analysis
protein analysis
cytology specimen collection procedure
laboratory biomarker analysis
questionnaire administration
Sponsored by
Cancer Research UK
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Adenocarcinoma of the Gastroesophageal Junction focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cancer Research UK at Cambridge Research InstituteRecruiting

Outcomes

Primary Outcome Measures

Creation of repository of blood, saliva, and tumor samples

Secondary Outcome Measures

Full Information

First Posted
August 20, 2009
Last Updated
August 9, 2013
Sponsor
Cancer Research UK
search

1. Study Identification

Unique Protocol Identification Number
NCT00963092
Brief Title
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

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2002 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Research UK

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
DNA analysis
Intervention Type
Genetic
Intervention Name(s)
RNA analysis
Intervention Type
Genetic
Intervention Name(s)
microarray analysis
Intervention Type
Genetic
Intervention Name(s)
protein analysis
Intervention Type
Other
Intervention Name(s)
cytology specimen collection procedure
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Creation of repository of blood, saliva, and tumor samples

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Caldas
Organizational Affiliation
Cancer Research UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Research UK at Cambridge Research Institute
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 0RE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Caldas
Phone
44-1223-404-420

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs