- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00735566
Antiangiogenic Factors in Gastric Cancer
October 16, 2012 updated by: Jun Ho Lee, National Cancer Center, Korea
The Role of Endogenous Antiangiogenic Factors in Gastric Cancer Progression
Endogenous antiangiogenic factors are related with gastric cancer progression.
Study Overview
Status
Completed
Conditions
Detailed Description
Gastric cancers have been known to secrete the proangiogenic cytokine VEGF in vitro and in vivo.
Tumor VEGF expression is correlated with the severity of disease in patients with gastric cancer and some authors have suggested using circulating VEGF as a prognostic factor or tumor marker.In addition to producing proangiogenic cytokines, recent data demonstrate that tumors can produce antiangiogenic cytokine as well.
It has been suggested that, in humans, the generation of antiangiogenic compounds in the presence of a primary tumor suppresses the growth of distant metastases.
This phenomenon has been demonstrated in mice and in patients with clear cell renal cancer, breast cancer, and colorectal cancer.
However, the presence of endogenous antiangiogenic cytokines in patients with gastric cancer has not been reported.
Study Type
Observational
Enrollment (Actual)
240
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Geonggi-do
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Goyang-si, Geonggi-do, Korea, Republic of, 410-0769
- National Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Eligible patients will undergo subtotal or total gastrectomy with D2 lymph node dissection
Description
Inclusion Criteria:
- Histologic diagnosis of gastric adenocarcinoma
- No other forms of cancer therapy, such as chemotherapy or radiotherapy for at least 3 weeks before the enrollment in study
- Performance status of 0, 1, 2 on the ECOG criteria
- ASA class I, II
- Patient compliance that allow adequate follow up
- Informed consent from patient or patient's relative.
Exclusion Criteria:
- Second primary malignancy
- EMR (Endoscopic mucosal resection) indication
- Laparoscopic gastrectomy
- Radiologic or clinical evidence of metastasis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relationship between antiangiogenic factor and tumor, node, metastasis
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival, treatment failure
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jun Ho Lee, M.D., Ph.D, Gastric Cancer Branch, National Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
August 13, 2008
First Submitted That Met QC Criteria
August 14, 2008
First Posted (Estimate)
August 15, 2008
Study Record Updates
Last Update Posted (Estimate)
October 18, 2012
Last Update Submitted That Met QC Criteria
October 16, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCCCTS 04-105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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