TuberculosisNCT00313066
Comparison the Level of CTGF Protein and Related Cytokine in Pleural Effusion
An observational study of Tuberculosis and Tuberculous Pleurisy, run by Taichung Veterans General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Tuberculous Pleurisy, Malignant Pleural Effusion
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Nov 2005to Nov 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with pleural effusion
Who cannot join
- HIV infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital
Taichung, Taiwan, 407
Shen Gwan Han, MD, +886-4-23592525 ext. 3217, 911B@vghtc.gov.tw
Shen Gwan Han, MD
About this study
Official title: Comparison the Level of CTGF Protein and Related Cytokine in Pleural Effusion Among Tuberculous Pleurisy and Malignant Pleural Effusion Patients
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.
Read the detailed description
Connective tissue growth factor (CTGF, also known as CCN2) is a member of the CCN family. Cysteine-rich 61(Cyr61) is known as CCN1, and nephroblastoma over-expressed (Nov, known as CCN3) as well as Wisp-1/elm1( CCN4),Wisp-2/rCop1(CCN5), and Wisp-3 (CCN6)1. The CTGF is a secretory growth factor that bind with integrins on the cell surface and was first identified as a mitogen isolated from the medium of human umbilical vein endothelial cells2. CTGF can be expressed in many human organs such as heart, brain, placenta, liver, muscle, kidney, and lung and may have many biologic functions3. CTGF stimulate the proliferation of fibroblast and vascular endothelial cells. The level of CTGF protein is increased in patients with various fibrotic human disease including renal failure, hepatic fibrosis in biliary atresia, systemic scleroderma and vascular atherosclerosis4.
Recent research revealed the expression of CTGF protein was high in the normal lung epithelium and moderate to high in stage I lung adenocarcinoma cells5. But the expression of CTGF was reduced in low grade metastatic respiratory epithelial tumor cells. The CTGF expression was associated with the suppression of human lung cancer cell metastasis in a mouse model and the reduced CTGF expression was also associated with clinical metastasis and patient survival5. The expression of CTGF protein was statistically significantly higher in normal lung type I and II epithelial cells than in the majority of metastatic adenocarcinoma specimens revealed that the level of CTGF protein decreases during clinical disease when cells acquire the ability to grow at metastatic site6. CTGF appears to be a suppressor of lung tumor invasion and 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. Connective tissue growth factor acts as an independent prognostic marker in colorectal cancer and giomas and inhibits metastasis7,8
- Keywords
- CTGF, fibrogenic cytokine, FGF, pleural fibrosis
- Medical subject headings
- Tuberculosis, Tuberculosis, Pleural, Pleural Effusion, Malignant, Empyema
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startNov 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Defined population
- Time perspective
- Other
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ton General Hospital
- Investigators
- Shen Gwan Han, MD, Principal investigator, Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313066
- Sponsor's protocol ID
- 940513/C05092
- Status last verified
- Apr 2006
- First submitted
- 9 Apr 2006
- Last updated
- 11 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Level of CTGF Protein and Related Cytokine in Pleural Effusion Among Tuberculous Pleurisy and Malignant Pleural Effusion Patients
- ClinicalTrials.gov ID
- NCT00313066
- Acronym / sponsor ID
- 940513/C05092
- Keywords
- CTGF, fibrogenic cytokine, FGF, pleural fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- Ton General Hospital
- Study start
- Nov 2005
- Study completion
- Nov 2006
- First posted
- 11 Apr 2006 (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.
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.
Detailed description
Connective tissue growth factor (CTGF, also known as CCN2) is a member of the CCN family. Cysteine-rich 61(Cyr61) is known as CCN1, and nephroblastoma over-expressed (Nov, known as CCN3) as well as Wisp-1/elm1( CCN4),Wisp-2/rCop1(CCN5), and Wisp-3 (CCN6)1. The CTGF is a secretory growth factor that bind with integrins on the cell surface and was first identified as a mitogen isolated from the medium of human umbilical vein endothelial cells2. CTGF can be expressed in many human organs such as heart, brain, placenta, liver, muscle, kidney, and lung and may have many biologic functions3. CTGF stimulate the proliferation of fibroblast and vascular endothelial cells. The level of CTGF protein is increased in patients with various fibrotic human disease including renal failure, hepatic fibrosis in biliary atresia, systemic scleroderma and vascular atherosclerosis4.
Recent research revealed the expression of CTGF protein was high in the normal lung epithelium and moderate to high in stage I lung adenocarcinoma cells5. But the expression of CTGF was reduced in low grade metastatic respiratory epithelial tumor cells. The CTGF expression was associated with the suppression of human lung cancer cell metastasis in a mouse model and the reduced CTGF expression was also associated with clinical metastasis and patient survival5. The expression of CTGF protein was statistically significantly higher in normal lung type I and II epithelial cells than in the majority of metastatic adenocarcinoma specimens revealed that the level of CTGF protein decreases during clinical disease when cells acquire the ability to grow at metastatic site6. CTGF appears to be a suppressor of lung tumor invasion and 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. Connective tissue growth factor acts as an independent prognostic marker in colorectal cancer and giomas and inhibits metastasis7,8
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with pleural effusion
Key exclusion criteria (1 listed)
- HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2006.
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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.
Shen Gwan Han, MD principal investigator
Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital
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 Tuberculosis and Tuberculous Pleurisy, run by Taichung Veterans General Hospital 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 1 inclusion and 1 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 11 Apr 2006. 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?
Contact Shen Gwan Han, MD (+886-4-23592525 ext. 3217, 911B@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 11 Apr 2006.