## Protocol Section
### Identification Module
**NCT ID:** NCT00257179

**Brief Title:** The Serum Tissue Factor Level in Lung Cancer Patients as a Prognostic Factor

#### Organization Study ID Info
**ID:** 9461700609
#### Organization
**Class:** OTHER
**Full Name:** National Taiwan University Hospital
### Status Module
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2006-03-14

**Type:** ESTIMATED

**Last Update Submit Date:** 2006-03-13

**Overall Status:** UNKNOWN

#### Start Date
**Date:** 2005-06

**Status Verified Date:** 2005-06

#### Study First Post Date
**Date:** 2005-11-22
**Type:** ESTIMATED
**Study First Submit Date:** 2005-11-21
**Study First Submit QC Date:** 2005-11-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Taiwan University Hospital

### Description Module

**Brief Summary:** This study uses serum tissue factor and tissue factor inhibitor and factor VII to monitor the pre-coagulation status in lung cancer patients and to correlate the pre-coagulation status with clinical staging and prognosis.

**Detailed Description:** The staging of lung cancer was according to tumor size, involvement of lymph node and metastatic status. But there is a different prognosis in cancer patients of the same stage. The coagulation status of cancer patients was considered as an important possible prognostic factor. So in this study, we want to evaluate patients' coagulation status and find the relation of coagulation status and cancer status.

We thus propose a prospective study using coagulation factors in order to search for the relationship between cancer stage and pre-coagulation status in Taiwanese lung cancer patients. We will also evaluate the potential use of tissue factor as a prognosis predictor in lung cancer patients.

### Conditions Module

**Conditions:**

- Lung Cancer

**Keywords:**

- Tissue factor

- Lung cancer

- Tissue factor protein inhibitor

- Factor VII

- Factor X

### Design Module

#### Design Info

**Observational Model:** NATURAL_HISTORY

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 200

**Study Type:** OBSERVATIONAL

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients with newly-diagnosed lung cancer
* Serum from cancer-free healthy volunteers

Exclusion Criteria:

* Chronic renal failure or end-stage renal disease \[ESRD\] (creatinine \[Cr\] \> 2 )
* Hyperlipidemia on statin therapy
* Acute myocardial infarction
* Tapal or Plavix use
* Active thromboembolic event
* Severe liver disease (\> child B)

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jeffery@ha.mc.ntuh.edu.tw

**Name:** Chong-Jen Yu, M.D., Ph.D.

**Phone:** 886-2-2356-2905

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Taipei

**Contacts:**

***Contact 1:***

- **Name:** Chong-Jen Yu, M.D., Ph.D.

- **Phone:** 886-2-2356-2905

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** National Taiwan University Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** National Taiwan University Hospital

**Name:** Chong-Jen Yu, M.D., Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Coag

- Name: Coagulants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M16684

- Name: Thromboplastin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
