Pleural Effusion, MalignantNCT05693727
Cancer Ratio,Pleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18}for Differentiation Between Malignant and Non Malignant Pleural Effusion
An observational study of Pleural Effusion, Malignant, run by Assiut University.
Trial summary
To evaluate the ability of cancer ratio and pleural fluid markers to discriminate between malignant and non malignant effusion Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Malignant
- What is being tested?
- pleural markers
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Sep 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
- No healthy volunteers
- Adult, Older adult
Study population: patients with exudative pleural effusion who will be admitted to Department of Chest diseases and Tuberculosis, Assiut University Hospital
Who may be able to join
- Patients (100 cases) with exudative pleural effusion who will be admitted to Department of Chest diseases and Tuberculosis, Assiut University Hospital
Who cannot join
- Age ˂ 18 years
- Refusal to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the ability of cancer ratio and pleural fluid markers to discriminate between malignant and non malignant effusion
Read the detailed description
Pleural effusion is a common clinical entity affecting approximately 1.5 million patients per year in the United States. {3.1}A large number of diseases may be associated with pleural effusion.
This includes:
- Local conditions affecting the pleura (eg, tuberculous pleurisy, pleural mesothelioma),
- Extrapulmonary diseases with secondary pleural involvement (eg, chronic heart failure, liver cirrhosis).
To date, differentiation between both types of pleural effusion (exudate and transudate) is the most common initial diagnostic approach for patients with pleural effusion.
Exudative effusion is commonly seen in three conditions namely cancer (MPE), tuberculosis (TB) and para pneumonic Although MPE can be diagnosed by simple pleural fluid cytology, this method has significant limitations, including a highly variable sensitivity, ranging from as low as 11.6% to as high as 71%.
In contrast to other common causes of pleural effusion such as T.B, no accurate biomarkers of MPE have been established.
Several tumor markers were extensively evaluated, including carcinoembryonic antigen, cytokeratin-19 fragments, and cancer antigen 125, but none of them were found sensitive and specific enough to be implemented in routine clinical practice
- Conditions
- Pleural Effusion, Malignant
- Being tested
- pleural markers
- 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.
pleural markersDiagnostic test
Pleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18}
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiate between malignant and non malignant pleural effusion by pleural markers
using pleural markers
Measured: Baseline
Secondary outcomes (1)
Time saving
decrease the need for invasive maneuvers for diagnosis
- decrease length of hospital stay
- decrease the development of complications
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Effusion, MalignantStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Adel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693727
- Sponsor's protocol ID
- Malignant pleural effusion
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 23 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Ratio,Pleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18}for Differentiation Between Malignant and Non Malignant Pleural Effusion
- ClinicalTrials.gov ID
- NCT05693727
- Acronym / sponsor ID
- Malignant pleural effusion
- Conditions
- Pleural Effusion, Malignant
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 23 Jan 2023 (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.
To evaluate the ability of cancer ratio and pleural fluid markers to discriminate between malignant and non malignant effusion
Detailed description
Pleural effusion is a common clinical entity affecting approximately 1.5 million patients per year in the United States. {3.1}A large number of diseases may be associated with pleural effusion.
This includes:
- Local conditions affecting the pleura (eg, tuberculous pleurisy, pleural mesothelioma),
- Extrapulmonary diseases with secondary pleural involvement (eg, chronic heart failure, liver cirrhosis).
To date, differentiation between both types of pleural effusion (exudate and transudate) is the most common initial diagnostic approach for patients with pleural effusion.
Exudative effusion is commonly seen in three conditions namely cancer (MPE), tuberculosis (TB) and para pneumonic Although MPE can be diagnosed by simple pleural fluid cytology, this method has significant limitations, including a highly variable sensitivity, ranging from as low as 11.6% to as high as 71%.
In contrast to other common causes of pleural effusion such as T.B, no accurate biomarkers of MPE have been established.
Several tumor markers were extensively evaluated, including carcinoembryonic antigen, cytokeratin-19 fragments, and cancer antigen 125, but none of them were found sensitive and specific enough to be implemented in routine clinical practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with exudative pleural effusion who will be admitted to Department of Chest diseases and Tuberculosis, Assiut University Hospital
Key inclusion criteria (1 listed)
- Patients (100 cases) with exudative pleural effusion who will be admitted to Department of Chest diseases and Tuberculosis, Assiut University Hospital
Key exclusion criteria (2 listed)
- Age ˂ 18 years
- Refusal to participate in the study
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 markersPleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18} | Diagnostic test | – |
Primary outcome
Differentiate between malignant and non malignant pleural effusion by pleural markers
Time frame: Baseline
using pleural markers
1 secondary outcome
Time saving
Time frame: Baseline
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 23 Jan 2023.
- Saguil A, Wyrick K, Hallgren J. Diagnostic approach to pleural effusion. Am Fam Physician. 2014 Jul 15;90(2):99-104. PMID: 25077579.Link provided by the sponsor.
- Ashutosh Nath Aggarwal, Ritesh Agarwal, Inderpaul Singh Sehgal, Sahajal Dhooria. Adenosine deaminase for diagnosis of tuberculous pleural effusion: A systematic review and meta-analysis. PLoS ONE 14(3): e0213728Link provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion, Malignant, run by Assiut 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 1 inclusion and 2 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 23 Jan 2023. 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 Mona Adel Mostafa, Master (01124629683, maiadel9995@gmail.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentiate between malignant and non malignant pleural effusion by pleural markers (time frame: Baseline). 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 23 Jan 2023.