Extrahepatic CholangiocarcinomaVEGF ECCNCT02103179
VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway (ECC)
An observational study of Extrahepatic Cholangiocarcinoma, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in ECC growth, proliferation and apoptosis. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Extrahepatic Cholangiocarcinoma
- What is being tested?
- surgical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jul 2006to Sep 2014
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Extrahepatic cholangiocarcinoma patients underwent surgical therapy
Who may be able to join
- Extrahepatic cholangiocarcinoma patients diagnosed through biopsy; two or more dynamic imagine with a diagnosis of Extrahepatic cholangiocarcinoma
- Child-Pugh A or B
- well preserved renal and hematopoietic Function
- receive surgical therapy
- achieve complete section accessed by contrast-enhanced CT
Who cannot join
- incomplete section
- remote metastasis
- Child-Pugh C
- combination with other hepatobiliary disease
- suffer from other tumors concurrently or in last five years
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
About this study
Official title: VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway
The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in ECC growth, proliferation and apoptosis.
Read the detailed description
Several studies have documented the elevated expression of VEGF, VEGFR1 and VEGFR2 in cancer cell lines. Another study observed a sequential elevation of VEGF in low-grade dysplasia, high-grade dysplasia and early stage liver cancer. Clinical analyses have discovered the high expression of VEGF is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. However, few studies have been conducted to investigate the VEGF signaling in ECC cells and its possible mechanism in regulating ECC growth.Therefore,we try to clarify the mechanism of VEGF signal in ECC growth,proliferation and apoptosis.
- Conditions
- Extrahepatic Cholangiocarcinoma
- Being tested
- surgical treatment
- Keywords
- Extrahepatic cholangiocarcinoma, ECC, VEGF signaling
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical treatmentProcedure or surgery
all the patients in the study must have been treated by the surgery at the first time and have been confirmed as 'complete section' by the post-surgery radiological image.
| Study group | Role | What they receive |
|---|---|---|
| ECC patients | Extrahepatic cholangiocarcinoma patients treated by surgical treatment Receives: Procedure: surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the variation of the quantity of VEGF signal pathway genes in normal liver tissue,peri tumor,tumor and metastasis.
the sections would be collected as previously described.Western blot,immunohistochemistry,PCR would be conducted to find out the variation between the normal liver tissue and tumor,tumor and meta(if have).
Measured: the day when conducting surgery (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startJul 2006
- Primary completionApr 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Province, Department of Science and Technology
- Responsible party
- Principal investigator, Ming Kuang,MD,PhD, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Ming Kuang, MD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103179
- Sponsor's protocol ID
- k0113011-2013ECC
- Acronym
- VEGF ECC
- Status last verified
- Mar 2014
- First submitted
- 31 Mar 2014
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway
- ClinicalTrials.gov ID
- NCT02103179
- Acronym / sponsor ID
- VEGF ECC / k0113011-2013ECC
- Conditions
- Extrahepatic Cholangiocarcinoma
- Keywords
- Extrahepatic cholangiocarcinoma, ECC, VEGF signaling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Guangdong Province, Department of Science and Technology
- Study start
- Jul 2006
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 3 Apr 2014 (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.
The investigators study the VEGF signaling in ECC cell lines,patients and its mechanism in ECC growth, proliferation and apoptosis.
Detailed description
Several studies have documented the elevated expression of VEGF, VEGFR1 and VEGFR2 in cancer cell lines. Another study observed a sequential elevation of VEGF in low-grade dysplasia, high-grade dysplasia and early stage liver cancer. Clinical analyses have discovered the high expression of VEGF is correlated with tumor progression, vascular invasion, distal metastasis and poor prognosis. However, few studies have been conducted to investigate the VEGF signaling in ECC cells and its possible mechanism in regulating ECC growth.Therefore,we try to clarify the mechanism of VEGF signal in ECC growth,proliferation and apoptosis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECC patients | – | Procedure: surgical treatmentExtrahepatic cholangiocarcinoma patients treated by surgical treatment |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Extrahepatic cholangiocarcinoma patients underwent surgical therapy
Key inclusion criteria (5 listed)
- Extrahepatic cholangiocarcinoma patients diagnosed through biopsy; two or more dynamic imagine with a diagnosis of Extrahepatic cholangiocarcinoma
- Child-Pugh A or B
- well preserved renal and hematopoietic Function
- receive surgical therapy
- achieve complete section accessed by contrast-enhanced CT
Key exclusion criteria (5 listed)
- incomplete section
- remote metastasis
- Child-Pugh C
- combination with other hepatobiliary disease
- suffer from other tumors concurrently or in last five years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical treatmentall the patients in the study must have been treated by the surgery at the first time and have been confirmed as 'complete section' by the post-surgery radiological image. | Procedure or surgery | ECC patients |
Primary outcome
the variation of the quantity of VEGF signal pathway genes in normal liver tissue,peri tumor,tumor and metastasis.
Time frame: the day when conducting surgery (day 1)
the sections would be collected as previously described.Western blot,immunohistochemistry,PCR would be conducted to find out the variation between the normal liver tissue and tumor,tumor and meta(if have).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
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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.
Ming Kuang, MD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
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 Extrahepatic Cholangiocarcinoma, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Apr 2014. 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 China. 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?
Results are not available in the source record.
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?
the variation of the quantity of VEGF signal pathway genes in normal liver tissue,peri tumor,tumor and metastasis. (time frame: the day when conducting surgery (day 1)). 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 3 Apr 2014.