Gastric CancerNCT00735566
Antiangiogenic Factors in Gastric Cancer
An observational study of Gastric Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Endogenous antiangiogenic factors are related with gastric cancer progression. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- How many people
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2006to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible patients will undergo subtotal or total gastrectomy with D2 lymph node dissection
Who may be able to join
- 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.
Who cannot join
- Second primary malignancy
- EMR (Endoscopic mucosal resection) indication
- Laparoscopic gastrectomy
- Radiologic or clinical evidence of metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Endogenous Antiangiogenic Factors in Gastric Cancer Progression
Endogenous antiangiogenic factors are related with gastric cancer progression.
Read the 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.
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, antiangiogenic factors, TNM stage
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between antiangiogenic factor and tumor, node, metastasis
Measured: One year
Secondary outcomes (1)
Overall survival, treatment failure
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startApr 2006
- Primary completionJul 2008
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jun Ho Lee, National Cancer Center, Korea
- Investigators
- Jun Ho Lee, M.D., Ph.D, Principal investigator, Gastric Cancer Branch, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735566
- Sponsor's protocol ID
- NCCCTS 04-105
- Status last verified
- Oct 2012
- First submitted
- 13 Aug 2008
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Endogenous Antiangiogenic Factors in Gastric Cancer Progression
- ClinicalTrials.gov ID
- NCT00735566
- Acronym / sponsor ID
- NCCCTS 04-105
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, antiangiogenic factors, TNM stage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Apr 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endogenous antiangiogenic factors are related with gastric cancer progression.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will undergo subtotal or total gastrectomy with D2 lymph node dissection
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Second primary malignancy
- EMR (Endoscopic mucosal resection) indication
- Laparoscopic gastrectomy
- Radiologic or clinical evidence of metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between antiangiogenic factor and tumor, node, metastasis
Time frame: One year
1 secondary outcome
Overall survival, treatment failure
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Ho Lee, M.D., Ph.D principal investigator
Gastric Cancer Branch, National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between antiangiogenic factor and tumor, node, metastasis (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2012.