NCT06657638

Brief Summary

Malignant pleural effusion (MPE) is characterized by the presence of malignant cells. It can occur in 15% of patients with cancer and is a common manifestation in patients with metastatic disease. Breast cancer (BC) is the second most common cause of MPE and MPE occurring in 2- 11% of patients with BC. Breast cancer is a heterogeneous disease of malignant tumors with diversified morphology, clinical course, biologic behavior and prognosis, and accurate tumor classification is critical for a patient's care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

October 23, 2024

Last Update Submit

May 27, 2025

Conditions

Keywords

malignant pleural effusionbreast cancerCytological examination

Outcome Measures

Primary Outcomes (1)

  • Cytological examination of pleural effusion in breast cancer ( cell/unit)

    Diagnosis of pleural effusion by cytological examination

    6 months

Study Arms (1)

Cancer breast

malignant pleural effusion in breast cancer

Diagnostic Test: Thoracentesis

Interventions

ThoracentesisDIAGNOSTIC_TEST

Aspiration of pleural effusion

Cancer breast

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCancer breast
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients are presented for thoracentesis with cytological examination of pleural effusion, if the appearance of visceral and parietal pleural was clearly and if malignant diagnosis of breast was confirmed on histological analysis of the biopsy material.

You may qualify if:

  • Patients will be included if they are presented for thoracentesis with routine cytological examination of pleural effusion before biopsy or thoracoscopy, if the appearance of visceral and parietal pleural was clearly and if malignant diagnosis of breast was confirmed on histological analysis of the biopsy material.

You may not qualify if:

  • Age \<18 years.
  • Patients diagnosed with malignant pleural mesothelioma (MPM)
  • Contraindication for pleurocentesis; patient refusing, coagulopathy and active skin infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed AbdElmoniem

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Pleural Effusion, MalignantBreast Neoplasms

Interventions

Thoracentesis

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ParacentesisSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Mohamed AbdElmoniem

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of chest medicine

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 24, 2024

Study Start

October 19, 2024

Primary Completion

January 19, 2025

Study Completion

April 19, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations