Antiangiogenic Factors in Gastric Cancer - Full Text View

Sponsored by:	National Cancer Center, Korea
Information provided by:	National Cancer Center, Korea
ClinicalTrials.gov Identifier:	NCT00735566

Purpose

Endogenous antiangiogenic factors are related with gastric cancer progression.

Condition
Gastric Cancer

MedlinePlus related topics: Cancer Stomach Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	The Role of Endogenous Antiangiogenic Factors in Gastric Cancer Progression

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:

Relationship between antiangiogenic factor and tumor, node, metastasis [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival, treatment failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Serum for protein assay using ELISA

Estimated Enrollment:	240
Study Start Date:	April 2006
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Eligible patients will undergo subtotal or total gastrectomy with D2 lymph node dissection

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735566

Contacts

Contact: Jun Ho Lee, M.D., Ph.D

82-31-920-1629

kosmas@ncc.re.kr

Locations

Korea, Republic of, Geonggi-do
National Cancer Center	Recruiting
Goyang-si, Geonggi-do, Korea, Republic of, 410-0769
Contact: Jun Ho Lee, M.D., Ph.D 82-31-920-1629 kosmas@ncc.re.kr

Sponsors and Collaborators

National Cancer Center, Korea

Investigators

Principal Investigator:	Jun Ho Lee, M.D., Ph.D	Gastric Cancer Branch, National Cancer Center
Principal Investigator:	Jun Ho Lee, M.D., Ph.D	Gastric Cancer Branch, National Cancer Center

More Information

Responsible Party:	National Cancer Center ( Jin Soo Lee/President )
Study ID Numbers:	NCCCTS 04-105
Study First Received:	August 13, 2008
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00735566
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by National Cancer Center, Korea:

gastric cancer
antiangiogenic factors
TNM stage

Study placed in the following topic categories:

Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases

Stomach Neoplasms
Disease Progression
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009