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Prognostic Value and Clinical Pathology of c-MET Expression and Amplification in Gastric Carcinoma

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ClinicalTrials.gov Identifier: NCT02002416
Recruitment Status : Unknown
Verified November 2013 by Ruihua Xu, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2013
Last Update Posted : December 5, 2013
Sponsor:
Information provided by (Responsible Party):
Ruihua Xu, Sun Yat-sen University

Brief Summary:

The MET oncogene encodes the receptor tyrosine kinase (RTK) for hepatocyte growth factor (HGF) and controls genetic programs leading to cell growth, invasion and protec¬tion from apoptosis. Although the definitive role of MET oncogene is yet to be determined in carcinogenesis of gastric cancer, overexpression and amplification of c-Met has been demonstrated in gastric cancer cell lines. In addition, approximately 10-20% of gastric cancer tissues and up to 40% of the scirrhous histological subtype were shown to harbor increased MET gene copy numbers. Importantly, PHA-665,752, a selective c-Met kinase inhibitor showed significant reduction of established tumor mass in mouse xenografts with GTL16, a gastric cancer cell line with >10-fold MET amplification. Another pivotal study showed that gastric cancer cells with MET amplification were extremely sensitive to PHA-665,752 and implicated a potential role of c-Met protein in developing theranostics in gastric cancer. More and more data indicated that c-Met was an important prognostic factor in gastric cancer.

Gastric cancer is a heterogeneous disease. Does the expression and amplification of c-Met in the primary lesion differ from the metastatic disease? Does the expression and amplification of c-Met in the early disease differ from advanced disease? Till now there is no related report.

Purposes:

  • Compare the expression and amplification of c-Met between primary lesion and metastatic lesion together with clinical characteristic, to explore the relationship of c-Met expression and metastatic pattern
  • Compare the expression and amplification of c-Met between early stage and metastatic stage, and to explore the role of c-MET in the development of carcinoma

Condition or disease
Gastric Cancer

Detailed Description:

We retrospectively collect the metastatic gastric cancer patients who received a surgical resection of both primary diseases and metastatic lesions during January 2006 and December 2012. Patients are collected based on the following criteria: (1) pathology proven advanced gastric adenocarcinoma; (2) the paraffin-embedded tissues of the primary and metastatic lesions were available (3) full information of follow-up. There are 100 patients suitable for the analysis. c-MET protein expression and amplification are assessed in paraffin-embedded tissues of the primary and metastatic diseases obtained from 100 patients by immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH). The clinical pathologic data of the patients are also collected for analysis, including: gender, age, Karnofsky performance score (KPS), chemotherapy regimens, tumor locations, Lauren classification, histology subtypes, metastatic sites.

In order compare c-Met expression and amplification between early and advanced stage, we will match 100 early stage (stage I and stage II) patients based on the following criteria (1) pathology proven gastric adenocarcinoma with radical resection; (2) the paraffin-embedded tissues of the primary lesions is available (3) full information of follow-up MET IHC will employ the Dako MET IHC assay and supplied assay protocol and pathology scoring guideline.

MET FISH will also employ the Dako MET FISH assay supplied assay protocol and pathology scoring guideline.


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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Prognostic Value and Clinical Pathology of c-MET Expression and Amplification in Gastric Carcinoma: the Comparison Between the Primary and Metastatic Lesions, Early Stage and Advanced Stage
Study Start Date : January 2006
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Group/Cohort
Metastatic gastric cancer patients
Selecte 100 cases of eligible metastatic gastric cancer patients with primary and metastatic lesion (1:1). Use the immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH) to detect the status of C-met.
Early stage gastric cancer
Selected 100 cases of eligible gastric cancer patients with previously early stage gastric cancer



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    From the diagnosis to the time of last follow up or death


Secondary Outcome Measures :
  1. Positive rate of C-met [ Time Frame: 8% ]
    The positive rate of c-met in the primary and metastastic diseases and in different stage diseases patients


Biospecimen Retention:   Samples Without DNA
Paraffin-embedded tumor tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We retrospectively collect the metastatic gastric cancer patients who received a surgical resection of both primary diseases and metastatic lesions during January 2006 and December 2012. c-MET protein expression and amplification are assessed in paraffin-embedded tissues of the primary and metastatic diseases obtained from 100 patients by immunohistochemistry (IHC) and Fluorescence in situ hybridization (FISH). In order to compare c-Met expression and amplification between early and advanced stage, we will match 100 early stage (stage I and stage II) patients. MET IHC will employ the Dako MET IHC assay and supplied assay protocol and pathology scoring guideline.
Criteria

Inclusion Criteria:

  1. For metastatic gastric cancer patients (1) pathology proven advanced gastric adenocarcinoma; (2) the paraffin-embedded tissues of the primary and metastatic lesions were available; (3) full information of follow-up
  2. For early stage gastric cancer patients (1) pathology proven gastric adenocarcinoma with radical resection; (2) the paraffin-embedded tissues of the primary lesions is available; (3) full information of follow-up

Exclusion Criteria:

  1. Older than 70 years old or younger than 18 years old
  2. without paraffin-embedded tissue
  3. without information of follow-up

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 ClinicalTrials.gov identifier (NCT number): NCT02002416


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Rui-hua Xu, MD, PhD Sun Yat-sen University

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Responsible Party: Ruihua Xu, Vice president, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02002416     History of Changes
Other Study ID Numbers: C-met in gastric cancer
Amgen ( Other Grant/Funding Number: Amgen )
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: November 2013

Keywords provided by Ruihua Xu, Sun Yat-sen University:
C-met expression, gastric cancer, overall survival

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