ClinicalTrials.gg
Not yet recruitingNCT05693727Updated Jan 23, 2023

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 in Pleural Effusion, Malignant, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-23.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Pleural Effusion, Malignant
03

In context

Pleural Effusion, Malignant

169 studies on the registry are indexed under Pleural Effusion, Malignant; 39 are open to participants now.

This study's planned enrollment of 100 is below the median of 112 across 37 observational studies indexed under Pleural Effusion, Malignant.

Browse Pleural Effusion, Malignant studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with exudative pleural effusion who will be admitted to Department of Chest diseases and Tuberculosis, Assiut University Hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients (100 cases) with exudative pleural effusion who will be admitted to Department of Chest diseases and Tuberculosis, Assiut University Hospital

Exclusion criteria

Exclusion Criteria:

  • Age ˂ 18 years
  • Refusal to participate in the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testpleural markers

    Pleural Fluid Adenosine Deaminase,Lactate Dehydrogenase, interferonY, Tumor Necrosis Factor,and Interleukins{2,12,18}

06

What researchers measure

Primary outcomes

  1. Differentiate between malignant and non malignant pleural effusion by pleural markers

    using pleural markers

    Time frame: Baseline

Secondary outcomes

  1. Time saving

    decrease the need for invasive maneuvers for diagnosis * decrease length of hospital stay * decrease the development of complications

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05693727
Lead sponsor
Assiut University
Responsible party
Mona Adel (Doctor, Assiut University) — Principal investigator
First posted
Jan 23, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Jan 23, 2023

Study contacts

Mona Adel Mostafa, Master
Contact
maiadel9995@gmail.co
01124629683

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion