## Protocol Section
### Identification Module
**NCT ID:** NCT02103179

**Acronym:** VEGF ECC

**Brief Title:** VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway (ECC)

**Official Title:** VEGF Signaling Promotes Cell Growth and Metastasis in Extrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway

#### Organization Study ID Info
**ID:** k0113011-2013ECC
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital, Sun Yat-Sen University
### Status Module
#### Completion Date
**Date:** 2014-09

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2014-04-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-03-31

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2014-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2006-07

**Status Verified Date:** 2014-03

#### Study First Post Date
**Date:** 2014-04-03
**Type:** ESTIMATED
**Study First Submit Date:** 2014-03-31
**Study First Submit QC Date:** 2014-03-31
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Guangdong Province, Department of Science and Technology

#### Lead Sponsor

**Class:** OTHER

**Name:** First Affiliated Hospital, Sun Yat-Sen University

#### Responsible Party

**Investigator Affiliation:** First Affiliated Hospital, Sun Yat-Sen University

**Investigator Full Name:** Ming Kuang,MD,PhD

**Investigator Title:** MD,PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Extrahepatic Cholangiocarcinoma

**Keywords:**

- Extrahepatic cholangiocarcinoma

- ECC

- VEGF signaling

### Design Module

#### Bio Spec

**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.

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Extrahepatic cholangiocarcinoma patients treated by surgical treatment

**Intervention Names:**

- Procedure: surgical treatment

**Label:** ECC patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ECC patients

**Description:** 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.

**Name:** surgical treatment

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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).

**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)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Extrahepatic cholangiocarcinoma patients diagnosed through biopsy; two or more dynamic imagine with a diagnosis of Extrahepatic cholangiocarcinoma
2. Child-Pugh A or B
3. well preserved renal and hematopoietic Function
4. receive surgical therapy
5. achieve complete section accessed by contrast-enhanced CT

Exclusion Criteria:

1. incomplete section
2. remote metastasis
3. Child-Pugh C
4. combination with other hepatobiliary disease
5. suffer from other tumors concurrently or in last five years

**Maximum Age:** 80 Years

**Minimum Age:** 16 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Extrahepatic cholangiocarcinoma patients underwent surgical therapy

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Guangzhou

**Country:** China

**Facility:** First Affiliated Hospital, Sun Yat-Sen University

**State:** Guangdong

**Zip:** 510000

#### Overall Officials

**Official 1:**

**Affiliation:** First Affiliated Hospital, Sun Yat-Sen University

**Name:** Ming Kuang, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M20426

- Name: Cholangiocarcinoma

- Relevance: HIGH

- As Found: Extrahepatic Cholangiocarcinoma

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T755

- Name: Bile Duct Cancer

- Relevance: HIGH

- As Found: Cholangiocarcinoma

### Condition Browse Module - Meshes

- ID: D000018281

- Term: Cholangiocarcinoma

### Misc Info Module

- Version Holder: 2024-05-24
