Malignant Pleural EffusionCRPLUS-MPE-TPENCT07766876
Cancer Ratio and Cancer Ratio Plus in Malignant and Tuberculous Pleural Effusions
An observational study of Malignant Pleural Effusion and Tuberculous Pleural Effusion, run by Sohag University.
Trial summary
This prospective observational analytical study aims to assess the diagnostic value of Cancer Ratio and Cancer Ratio Plus in differentiating malignant pleural effusion from tuberculous pleural effusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion, Tuberculous Pleural Effusion
- What is being tested?
- Cancer Ratio and Cancer Ratio Plus
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: The study will include patients presenting with malignant or tuberculous pleural effusions who are admitted to the Chest Diseases Department of Sohag University hospital
Who may be able to join
- Adult patients (≥18 years)
- Patients with Malignant or tuberculous pleural effusion
- Availability of complete pleural fluid analysis including lymphocyte percentage ,pleural fluid ADA, and Serum LDH level
Who cannot join
- Patients with mixed etiology effusions (e.g., malignancy with infection)
- Prior pleural interventions affecting fluid analysis
- Incomplete clinical or laboratory data
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Enas K Ahmed, Lecturer contact
About this study
Official title: Role of Cancer Ratio and Cancer Ratio Plus in the Differentiation Between Malignant and Tuberculous Pleural Effusions .
This prospective observational analytical study aims to assess the diagnostic value of Cancer Ratio and Cancer Ratio Plus in differentiating malignant pleural effusion from tuberculous pleural effusion. Adult patients with confirmed malignant or tuberculous pleural effusion will be recruited from the Chest Diseases Department, Sohag University Hospitals. Clinical, laboratory, and radiological data will be collected, and the diagnostic performance of both markers will be evaluated.
- Being tested
- Cancer Ratio and Cancer Ratio Plus
- Keywords
- Cancer ratio, Cancer ratio plus, Serum LDH, Pleural fluid ADA, Pleural fluid analysis
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Ratio and Cancer Ratio PlusDiagnostic test
Cancer Ratio and Cancer Ratio Plus will be calculated using serum LDH, pleural fluid ADA, and pleural fluid lymphocyte percentage to assess their diagnostic value in differentiating malignant pleural effusion from tuberculous pleural effusion.
- Cancer Ratio CR =Serum LDH /pleural fluid ADA .
- Cancer Ratio Plus = Serum LDH/(pleural fluid ADA × pleural fluid Lymphocyte fraction )
| Study group | Role | What they receive |
|---|---|---|
| Malignant pleural effusion | Not described Receives: Diagnostic Test: Cancer Ratio and Cancer Ratio Plus | |
| Tuberculous pleural effusion | Not described Receives: Diagnostic Test: Cancer Ratio and Cancer Ratio Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of Cancer Ratio and Cancer Ratio Plus in differentiating malignant from tuberculous pleural effusions
Diagnostic performance will be assessed by the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and optimal cutoff values for differentiating malignant pleural effusion from tuberculous pleural effusion.
Measured: through study completion, an average of 1 year.
Secondary outcomes (1)
Correlation of Cancer Ratio and Cancer Ratio Plus with clinical and radiological characteristics
Assessment of the association between Cancer Ratio and Cancer Ratio Plus values and the clinical and radiological characteristics of patients with malignant and tuberculous pleural effusions.
Measured: through study completion , an average of 1 year .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766876
- Sponsor's protocol ID
- Soh-Med-26-7-19MS
- Acronym
- CRPLUS-MPE-TPE
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cancer Ratio and Cancer Ratio Plus in the Differentiation Between Malignant and Tuberculous Pleural Effusions .
- ClinicalTrials.gov ID
- NCT07766876
- Acronym / sponsor ID
- CRPLUS-MPE-TPE / Soh-Med-26-7-19MS
- Keywords
- Cancer ratio, Cancer ratio plus, Serum LDH, Pleural fluid ADA, Pleural fluid analysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 17 Aug 2026 (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.
This prospective observational analytical study aims to assess the diagnostic value of Cancer Ratio and Cancer Ratio Plus in differentiating malignant pleural effusion from tuberculous pleural effusion. Adult patients with confirmed malignant or tuberculous pleural effusion will be recruited from the Chest Diseases Department, Sohag University Hospitals. Clinical, laboratory, and radiological data will be collected, and the diagnostic performance of both markers will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malignant pleural effusion | – | Diagnostic Test: Cancer Ratio and Cancer Ratio Plus |
| Tuberculous pleural effusion | – | Diagnostic Test: Cancer Ratio and Cancer Ratio Plus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will include patients presenting with malignant or tuberculous pleural effusions who are admitted to the Chest Diseases Department of Sohag University hospital
Key inclusion criteria (3 listed)
- Adult patients (≥18 years)
- Patients with Malignant or tuberculous pleural effusion
- Availability of complete pleural fluid analysis including lymphocyte percentage ,pleural fluid ADA, and Serum LDH level
Key exclusion criteria (3 listed)
- Patients with mixed etiology effusions (e.g., malignancy with infection)
- Prior pleural interventions affecting fluid analysis
- Incomplete clinical or laboratory data
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 |
|---|---|---|
| Cancer Ratio and Cancer Ratio PlusCancer Ratio and Cancer Ratio Plus will be calculated using serum LDH, pleural fluid ADA, and pleural fluid lymphocyte percentage to assess their diagnostic value in differentiating malignant pleural effusion from tuberculous pleural effusion. 1. Cancer Ratio CR =Serum LDH /pleural fluid ADA . 2. Cancer Ratio Plus = Serum LDH/(pleural fluid ADA × pleural fluid Lymphocyte fraction ) | Diagnostic test | Malignant pleural effusion, Tuberculous pleural effusion |
Primary outcome
Diagnostic performance of Cancer Ratio and Cancer Ratio Plus in differentiating malignant from tuberculous pleural effusions
Time frame: through study completion, an average of 1 year.
Diagnostic performance will be assessed by the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and optimal cutoff values for differentiating malignant pleural effusion from tuberculous pleural effusion.
1 secondary outcome
Correlation of Cancer Ratio and Cancer Ratio Plus with clinical and radiological characteristics
Time frame: through study completion , an average of 1 year .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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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.
Enas K Ahmed, Lecturer contact
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Pleural Effusion and Tuberculous Pleural Effusion, run by Sohag University.
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: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina MA Mohamed Ahmed, M.B.B.Ch. (+201112561650, Dina.Mohamed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of Cancer Ratio and Cancer Ratio Plus in differentiating malignant from tuberculous pleural effusions (time frame: through study completion, an average of 1 year.). 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 17 Aug 2026.