Intrahepatic CholangiocarcinomaiccNCT01917370
VEGF Signaling Promotes Cell Growth and Metastasis in Intrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway
An observational study of Intrahepatic Cholangiocarcinoma, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The investigators study the VEGF signaling in ICC cell lines／human tissues and its mechanism in HCC growth, proliferation and apoptosis. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- surgical treatment
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Dec 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 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: intrahepatic cholangiocarcinoma patients underwent surgical therapy
Who may be able to join
- hepatocellular patients diagnosed through biopsy;or either dynamic imagine with a diagnosis of intrahepatic cholangiocarcinoma and CA199>100U/L；or two or more dynamic imagine with a diagnosis of intrahepatic cholangiocarcinoma
- Child-Pugh A or B
- well preserved renal and hematopoietic Function
- receive complete surgical therapy
- achieve complete section accessed by contrast-enhanced CT
Who cannot join
- incomplete section
- 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 Intrahepatic Cholangiocarcinoma in a VEGF
The investigators study the VEGF signaling in ICC cell lines／human tissues and its mechanism in HCC growth, proliferation and apoptosis.
Read the detailed description
Several studies have documented the elevated expression of VEGF and its receptors in ICC cell lines and tumor tissues. Another study observed that the elevation of VEGF promotes the growth. 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 ICC cells and its possible mechanism in regulating ICC growth.Therefore,we try to clarify the mechanism of VEGF signal in ICC growth,proliferation and apoptosis.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- surgical treatment
- Keywords
- intrahepatic cholangiocarcinoma, icc, vegf signal pathway
- Medical subject headings
- Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical treatmentProcedure or surgery
Also called hepatectomy
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 |
|---|---|---|
| ICC patients | patients with intrahepatic cholangiocarcinoma 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 posted6 Aug 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic 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
- Prospective
- 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
- NCT01917370
- Sponsor's protocol ID
- k0113011-2013ICC
- Acronym
- icc
- Status last verified
- Aug 2013
- First submitted
- 5 Aug 2013
- Last updated
- 6 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEGF Signaling Promotes Cell Growth and Metastasis in Intrahepatic Cholangiocarcinoma in a VEGF
- ClinicalTrials.gov ID
- NCT01917370
- Acronym / sponsor ID
- icc / k0113011-2013ICC
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- intrahepatic cholangiocarcinoma, icc, vegf signal pathway
- 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
- Oct 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 6 Aug 2013 (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 ICC cell lines／human tissues and its mechanism in HCC growth, proliferation and apoptosis.
Detailed description
Several studies have documented the elevated expression of VEGF and its receptors in ICC cell lines and tumor tissues. Another study observed that the elevation of VEGF promotes the growth. 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 ICC cells and its possible mechanism in regulating ICC growth.Therefore,we try to clarify the mechanism of VEGF signal in ICC growth,proliferation and apoptosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICC patients | – | Procedure: surgical treatmentpatients with intrahepatic cholangiocarcinoma treated by surgical treatment |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- intrahepatic cholangiocarcinoma patients underwent surgical therapy
Key inclusion criteria (5 listed)
- hepatocellular patients diagnosed through biopsy;or either dynamic imagine with a diagnosis of intrahepatic cholangiocarcinoma and CA199>100U/L；or two or more dynamic imagine with a diagnosis of intrahepatic cholangiocarcinoma
- Child-Pugh A or B
- well preserved renal and hematopoietic Function
- receive complete surgical therapy
- achieve complete section accessed by contrast-enhanced CT
Key exclusion criteria (4 listed)
- incomplete section
- 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 treatmentAlso: hepatectomyall 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 | ICC 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 6 Aug 2013.
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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 Intrahepatic 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 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: status not confirmed, as of the sponsor's last update on 6 Aug 2013. 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 6 Aug 2013.