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HER2 Circulating Tumor Cells in Gastric Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Won Ki Kang, Samsung Medical Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01299688
First Posted: February 18, 2011
Last Update Posted: June 14, 2013
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.
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center
  Purpose
The investigators propose to survey the frequency of HER2 (+) CTC in order to lay groundwork for future clinical trials incorporating Her-2 targeted agents in gastric cancer.

Condition
Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: HER2 Circulating Tumor Cells in Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Won Ki Kang, Samsung Medical Center:

Primary Outcome Measures:
  • To survey the frequency of HER2(+) CTC in gastric cancer [ Time Frame: 24month ]

Biospecimen Retention:   Samples Without DNA
blood, circulating tumor cell

Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: September 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Detailed Description:
We propose to survey the frequency of HER2 (+) CTC in order to lay groundwork for future clinical trials incorporating Her-2 targeted agents in gastric cancer. Blood samples will be collected from metastatic gastric cancer patients.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
metastatic gastric cancer
Criteria

Inclusion Criteria:

  • Patients older than 18 years ② Patients with localized, histologically confirmed gastric cancer ③ Informed consent form

Exclusion Criteria:

  • No informed consent form
  Contacts and Locations
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): NCT01299688


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Won Ki Kang, MD Samsung Medical Center
  More Information

Responsible Party: Won Ki Kang, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01299688     History of Changes
Other Study ID Numbers: 2009-12-008
First Submitted: February 17, 2011
First Posted: February 18, 2011
Last Update Posted: June 14, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplastic Cells, Circulating
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes