NCT00313066

Brief Summary

Connective tissue growth factor (CTGF) is known to be a fibrogenic cytokine, it could be expressed in various fibrosis diseases. But, recent research showed that CTGF also be considered to be a tumor suppressive gene. The expression of CTGF protein is higher in normal Type I and II alveolar epithelial cells than metastatic tumor cells. CTGF appears to be a suppressor of lung tumor invasion and in metastasis and the decreased CTGF expression in tumor tissues was associated with advanced tumor stage, lymph node metastasis, early postoperative relapse and shorter patient survival. CTGF can be expressed in many human organs such as heart, brain, placenta, liver, muscle, kidney, peritoneal mesothelial cells and lung but did not known in the pleura. The CTGF protein is present in the peritoneal cavity and is increased during peritonitis. Considering pleural cavity comes from the same origin of mesenchyma with peritoneum, pericardium and fallopian tube, we aim to evaluate whether the CTGF expression increase in the pleurisy patients including the parapneumonic effusion and the TB pleurisy. The diagnosis of TB pleurisy depends on the effusion TB culture and pleural biopsy. Unfortunately the sensitivity of TB culture was only 20-30%. So most patients must receive invasive pleural biopsy. Adenosine deaminase(ADA) was developed as a screening test but should not be considered an alternative test to culture and biopsy. The sensitivity of ADA might vary from 32%-100% and the cutoff value also vary from 26 to 70 IU/L. We should develop a method to alternate the culture and biopsy . Therefore, our technologist Jao-Jia chu will develop the CTGF ELISA kit for this specific aim. If CGTF might increase expression in pleuritis but decrease in pleural metastasis, it might be a potential method help to differentiate lymphocytic pleural effusion between TB pleurisy and malignancy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

April 11, 2006

Status Verified

April 1, 2006

First QC Date

April 9, 2006

Last Update Submit

April 9, 2006

Conditions

Keywords

CTGFfibrogenic cytokineFGFpleural fibrosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- patients with pleural effusion

You may not qualify if:

  • HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital

Taichung, Taiwan, 407, China

RECRUITING

MeSH Terms

Conditions

TuberculosisTuberculosis, PleuralPleural Effusion, MalignantEmpyema

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsTuberculosis, ExtrapulmonaryRespiratory Tract InfectionsPleural DiseasesRespiratory Tract DiseasesPleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionSuppurationInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shen Gwan Han, MD

    Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shen Gwan Han, MD

CONTACT

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2006

First Posted

April 11, 2006

Study Start

November 1, 2005

Study Completion

November 1, 2006

Last Updated

April 11, 2006

Record last verified: 2006-04

Locations