NCT00735566

Brief Summary

Endogenous antiangiogenic factors are related with gastric cancer progression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

October 18, 2012

Status Verified

October 1, 2012

Enrollment Period

2.3 years

First QC Date

August 13, 2008

Last Update Submit

October 16, 2012

Conditions

Gastric Cancer

Keywords

gastric cancerantiangiogenic factorsTNM stage

Outcome Measures

Primary Outcomes (1)

  • Relationship between antiangiogenic factor and tumor, node, metastasis

    One year

Secondary Outcomes (1)

  • Overall survival, treatment failure

    5 years

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Second primary malignancy
  • EMR (Endoscopic mucosal resection) indication
  • Laparoscopic gastrectomy
  • Radiologic or clinical evidence of metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Geonggi-do, 410-0769, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum for protein assay using ELISA

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Jun Ho Lee, M.D., Ph.D

    Gastric Cancer Branch, National Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Surgeon

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 15, 2008

Study Start

April 1, 2006

Primary Completion

July 1, 2008

Study Completion

January 1, 2012

Last Updated

October 18, 2012

Record last verified: 2012-10

Locations

KR(1)