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Tumor Markers Study in Gastric Cancer for Cancer Immunotherapy (ONCO-RD 010 CRT) (ONCO-RD010CRT)

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: NCT02686424
Recruitment Status : Suspended (paperwork delay)
First Posted : February 19, 2016
Last Update Posted : February 23, 2016
Information provided by (Responsible Party):
Woo Ho Kim, Seoul National University Hospital

Brief Summary:

Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Despite advances in therapeutic intervention, the mortality from this disease remains high. As a result, most patients are now offered varying combinations of surgery, chemotherapy, and radiation therapy in order to derive benefits from a multidisciplinary approach. Unfortunately, therapies are often toxic or debilitating and therapeutic responses can vary. Thus new therapeutic strategy is required for the treatment of gastric cancer.

In the early 1980s, the discovery of cytolytic T cells (cytolytic T lymphocytes, CTLs) directed against an antigen presented on tumor cells was published. They can kill many invasive cells by recognizing the tumor specific antigens on the major histocompatibility complex (MHC) molecules. It is now generally agreed that although tumors express tumor antigens, they usually lack immunogenicity because of their inability to activate the immune response. The current view is that tumor cells are antigenic, but not immunogenic. If we can artificially activate the immune system against the tumor, it may be possible to eradicate the tumor. This approach is the basis of cancer immunotherapy.

Many tumor antigens have been defined in terms of multiple solid tumors: MART-1/Melan-A, gp100, carcinoembryonic antigen (CEA), HER-2, mucins (i.e., MUC-1), prostate-specific antigen (PSA), and prostatic acid phosphatase (PAP) are just a short list. Some immune-based therapies targeting these tumor antigens are in phase III trials assessing whether immunizing against these antigens affects overall survival. In gastric cancer, some tumor antigens such as MAGE-A3, NY-ESO-1, and WT-1 have been reported to be expressed in substantial proportion of cases. They have the potential to be the targeting molecules for immunotherapy in the future. In this study, we aim to explore the expression levels of the four tumor markers (MAGE-A3, NY-ESO-1, WT-1 and PRAME) in gastric cancers of Korean patients and to examine the correlations of the expression levels of the four markers to clinic-patholoical factors.

Condition or disease
Stomach Neoplasms

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Tumor Markers Study in Gastric Cancer for Cancer Immunotherapy
Study Start Date : March 2010
Actual Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Primary Outcome Measures :
  1. overall survival [ Time Frame: five years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Gastric carcinoma patients who received ghastrectomy

Inclusion Criteria:

  • gastric carcinoma
  • received gastrectomy

Exclusion Criteria:

  • neoadjuvant therapy

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Responsible Party: Woo Ho Kim, Professor, Seoul National University Hospital Identifier: NCT02686424     History of Changes
Other Study ID Numbers: ONCO-RD 010 CRT (114824)
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Woo Ho Kim, Seoul National University Hospital:
MAGE-A3 protein
NY-ESO-1 protein
WT1 Proteins
PRAME protein

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases