Pleural EffusionNCT06729931
Quantitative C-Reactive Protein for Differentiating Tuberculous and Malignant Pleural Effusion: a Cross-Sectional Study
An observational study of Pleural Effusion and Malignant Pleural Effusions, run by Maharajgunj Medical Campus at 1 site in Nepal.
Trial summary
The goal of this observational study is to evaluate the role of pleural fluid Quantitative C-Reactive Protein (Q-CRP) levels in distinguishing between tuberculous and malignant pleural effusion in adult patients with lymphocytic exudative pleural effusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Malignant Pleural Effusions, Tuberculous Pleural Effusion
- What is being tested?
- Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement
- How many people
- 81 participants
- Where
- 1 siteNepal
- Study dates
- 1 Nov 2022to 15 Dec 2023
- 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
Study population: The study population consists of adult patients aged 18 years and above who presented with lymphocytic exudative pleural effusion at the Thoracic Surgery Unit, Department of CTVS, MCVTC, and the Department of Pulmonology, TUTH, Kathmandu, Nepal. Participants were recruited based on specific inclusion and exclusion criteria. Diagnostic evaluations, including pleural fluid analysis and additional testing (e.g., ADA, AFB, GeneXpert, cytology, or biopsy), were conducted to classify cases as tuberculous or malignant pleural effusion. Only confirmed cases of these conditions were included in the final analysis.
Who may be able to join
- Adults aged 18 years and older.
- Patients presenting with lymphocytic exudative pleural effusion confirmed by Light's criteria.
- Lymphocyte predominance in pleural fluid (≥ 50% of differential count).
Who cannot join
- Patients who refuse to provide consent for study participation.
- Patients requiring biopsy under general anesthesia but found unfit for the procedure.
- Non-tuberculous and non-malignant lymphocytic exudative pleural effusions identified during diagnostic evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative C-Reactive Protein for Differentiation Between Tuberculous and Malignant Pleural Effusion: an Institutional Cross-Sectional Study
The goal of this observational study is to evaluate the role of pleural fluid Quantitative C-Reactive Protein (Q-CRP) levels in distinguishing between tuberculous and malignant pleural effusion in adult patients with lymphocytic exudative pleural effusion.
The main questions it aims to answer are:
Read more
Is pleural fluid Q-CRP significantly higher in tuberculous pleural effusion compared to malignant pleural effusion? What is the optimal cutoff value of pleural fluid Q-CRP to differentiate between these conditions?
Participants will:
Undergo diagnostic procedures such as pleural fluid analysis, including ADA and cytology.
Provide pleural fluid samples for Q-CRP measurement. Have additional diagnostic imaging or biopsies if clinically indicated.
Researchers will compare Q-CRP levels between the tuberculous pleural effusion group and the malignant pleural effusion group to determine its diagnostic accuracy, including sensitivity, specificity, and predictive value.
- Being tested
- Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement
- Medical subject headings
- Pleural Effusion, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) MeasurementDiagnostic test
Also called Pleural Fluid CRP, Quantitative CRP Analysis
The intervention involves the measurement of Quantitative C-Reactive Protein (Q-CRP) levels in pleural fluid obtained from patients presenting with lymphocytic exudative pleural effusion. The Q-CRP test is performed using standardized laboratory methods to quantitatively analyze CRP levels, which are then compared between patients with confirmed tuberculous pleural effusion and those with malignant pleural effusion. This diagnostic approach aims to evaluate the efficacy of pleural fluid Q-CRP as a biomarker to differentiate between these two conditions. No therapeutic or invasive interventions are introduced as part of this study beyond routine diagnostic procedures.
| Study group | Role | What they receive |
|---|---|---|
| Tuberculous Pleural Effusion | Patients diagnosed with tuberculous pleural effusion based on pleural fluid ADA, AFB/GeneXpert, or pleural/lung tissue biopsy. Receives: Diagnostic Test: Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement | |
| Malignant Pleural Effusion | Patients diagnosed with malignant pleural effusion through pleural fluid cytology or pleural/lung tissue biopsy, supported by radiological findings. Receives: Diagnostic Test: Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Levels Between Tuberculous and Malignant Pleural Effusion
The primary outcome is the difference in pleural fluid Quantitative C-Reactive Protein (Q-CRP) levels between patients diagnosed with tuberculous pleural effusion and those with malignant pleural effusion. The study evaluates the diagnostic utility of Q-CRP levels as a biomarker by comparing mean values, sensitivity, specificity, and Area Under the Receiver Operating Characteristic (ROC) curve for differentiation between the two conditions.
Measured: Within 1 year (from November 2022 to October 2023)
Secondary outcomes (1)
Sensitivity and Specificity of Pleural Fluid Q-CRP Cut-off Values for Differentiating Tuberculous and Malignant Pleural Effusion
The secondary outcome evaluates the diagnostic performance of pleural fluid Q-CRP cut-off levels derived from the ROC curve analysis. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) are calculated to assess the utility of Q-CRP in accurately differentiating tuberculous pleural effusion from malignant pleural effusion.
Measured: Within 1 year (from November 2022 to October 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Nov 2022
- Primary completion1 Nov 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharajgunj Medical Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asim Shrestha, Maharajgunj Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729931
- Sponsor's protocol ID
- 225(6-11)E2079/080
- Status last verified
- Dec 2024
- First submitted
- 7 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon reasonable request for research purposes following publication of the study results
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative C-Reactive Protein for Differentiation Between Tuberculous and Malignant Pleural Effusion: an Institutional Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06729931
- Acronym / sponsor ID
- 225(6-11)E2079/080
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Maharajgunj Medical CampusUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 12 Dec 2024 (actual)
- 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.
The goal of this observational study is to evaluate the role of pleural fluid Quantitative C-Reactive Protein (Q-CRP) levels in distinguishing between tuberculous and malignant pleural effusion in adult patients with lymphocytic exudative pleural effusion.
The main questions it aims to answer are:
Is pleural fluid Q-CRP significantly higher in tuberculous pleural effusion compared to malignant pleural effusion? What is the optimal cutoff value of pleural fluid Q-CRP to differentiate between these conditions?
Participants will:
Undergo diagnostic procedures such as pleural fluid analysis, including ADA and cytology.
Provide pleural fluid samples for Q-CRP measurement. Have additional diagnostic imaging or biopsies if clinically indicated.
Researchers will compare Q-CRP levels between the tuberculous pleural effusion group and the malignant pleural effusion group to determine its diagnostic accuracy, including sensitivity, specificity, and predictive value.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tuberculous Pleural Effusion | – | Diagnostic Test: Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) MeasurementPatients diagnosed with tuberculous pleural effusion based on pleural fluid ADA, AFB/GeneXpert, or pleural/lung tissue biopsy. |
| Malignant Pleural Effusion | – | Diagnostic Test: Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) MeasurementPatients diagnosed with malignant pleural effusion through pleural fluid cytology or pleural/lung tissue biopsy, supported by radiological findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 years and above who presented with lymphocytic exudative pleural effusion at the Thoracic Surgery Unit, Department of CTVS, MCVTC, and the Department of Pulmonology, TUTH, Kathmandu, Nepal. Participants were recruited based on specific inclusion and exclusion criteria. Diagnostic evaluations, including pleural fluid analysis and additional testing (e.g., ADA, AFB, GeneXpert, cytology, or biopsy), were conducted to classify cases as tuberculous or malignant pleural effusion. Only confirmed cases of these conditions were included in the final analysis.
Key inclusion criteria (3 listed)
- Adults aged 18 years and older.
- Patients presenting with lymphocytic exudative pleural effusion confirmed by Light's criteria.
- Lymphocyte predominance in pleural fluid (≥ 50% of differential count).
Key exclusion criteria (3 listed)
- Patients who refuse to provide consent for study participation.
- Patients requiring biopsy under general anesthesia but found unfit for the procedure.
- Non-tuberculous and non-malignant lymphocytic exudative pleural effusions identified during diagnostic evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) MeasurementAlso: Pleural Fluid CRP, Quantitative CRP AnalysisThe intervention involves the measurement of Quantitative C-Reactive Protein (Q-CRP) levels in pleural fluid obtained from patients presenting with lymphocytic exudative pleural effusion. The Q-CRP test is performed using standardized laboratory methods to quantitatively analyze CRP levels, which are then compared between patients with confirmed tuberculous pleural effusion and those with malignant pleural effusion. This diagnostic approach aims to evaluate the efficacy of pleural fluid Q-CRP as a biomarker to differentiate between these two conditions. No therapeutic or invasive interventions are introduced as part of this study beyond routine diagnostic procedures. | Diagnostic test | Malignant Pleural Effusion, Tuberculous Pleural Effusion |
Primary outcome
Comparison of Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Levels Between Tuberculous and Malignant Pleural Effusion
Time frame: Within 1 year (from November 2022 to October 2023)
The primary outcome is the difference in pleural fluid Quantitative C-Reactive Protein (Q-CRP) levels between patients diagnosed with tuberculous pleural effusion and those with malignant pleural effusion. The study evaluates the diagnostic utility of Q-CRP levels as a biomarker by comparing mean values, sensitivity, specificity, and Area Under the Receiver Operating Characteristic (ROC) curve for differentiation between the two conditions.
1 secondary outcome
Sensitivity and Specificity of Pleural Fluid Q-CRP Cut-off Values for Differentiating Tuberculous and Malignant Pleural Effusion
Time frame: Within 1 year (from November 2022 to October 2023)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request for research purposes following publication of the study results
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pleural Effusion and Malignant Pleural Effusions, run by Maharajgunj Medical Campus at 1 site in Nepal.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 12 Dec 2024. 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 Nepal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Pleural Fluid Quantitative C-Reactive Protein (Q-CRP) Levels Between Tuberculous and Malignant Pleural Effusion (time frame: Within 1 year (from November 2022 to October 2023)). It is what the study was designed to measure, not a finding.
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 12 Dec 2024.