VEGF Signaling Promotes Cell Growth and Metastasis in Ext... | NCT02103179

Studies
VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway (ECC)

NCT02103179

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Unknown status

Last Update Posted

Apr 3, 2014Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Extrahepatic Cholangiocarcinoma

Interventions

surgical treatment

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Apr 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

Mar 31, 2014

First Submission Date that Met QC Criteria

Mar 31, 2014

First Posted Date

Apr 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2014

Last Update Posted Date

Apr 3, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ming Kuang,MD,PhD, MD,PhD, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Name	Class
Guangdong Province, Department of Science and Technology	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ECC patients		Extrahepatic cholangiocarcinoma patients treated by surgical treatment	Procedure: surgical treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgical treatment	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	the day when conducting surgery (day 1)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

incomplete section
remote metastasis
Child-Pugh C
combination with other hepatobiliary disease
suffer from other tumors concurrently or in last five years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Extrahepatic cholangiocarcinoma patients underwent surgical therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ming Kuang, MD	First Affiliated Hospital, Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital, Sun Yat-Sen University		Guangzhou	Guangdong	510000	China

Condition Browse Module

MeSH Terms

ID	Term
D018281	Cholangiocarcinoma

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Cut tissue into small pieces (~2 mm2)and wash in drops of saline (1x PBS). Place pieces individually into LN2 in Styrofoam cup. Transfer pieces into LN2-cooled 1.5 mL cryovial. Pour out excess LN2 from vial, then seal and keep in LN2 until freezer storage.