Prognostic Factors on Malignant Pleural Effusion

October 10, 2018 updated by: Lui Mei Sze, The University of Hong Kong

A Cohort Study of Prognostic Factors in Lung Cancer Patients With Malignant Pleural Effusion (MPE).

Malignant pleural effusion can occur in up to half of the patients with metastatic disease. It can cause shortness of breath to patients and so far there is no protocol on its management.

The study is looking at patients with malignant pleural effusion and aims to identify its prognostic factors.

Pleural fluid and blood analysis will be performed as in the standard of care and results will be collected at the start of diagnosis. This will not affect subsequent management plan. Patients' disease course will be followed up and progress data will be collected. Data will then be analysed to identify relevant prognostic factors.

Study Overview

Status

Completed

Conditions

Detailed Description

Malignant pleural effusion (MPE) is common, and is estimated to affect up to a half of patients with malignancy, either at the time or during subsequent clinical course after the diagnosis of malignancy. Lung cancer is the most common cause of MPE, followed by breast cancer, lymphoma, unknown primary genitourinary and gastrointestinal carcinoma. Pleural involvement indicates dissemination of malignancy and suggests a poorer prognosis and the median survival rate ranges from 3 to 12 months, with lung cancer showing the shortest survival among Caucasian cohorts. Patients with MPE frequently suffer from effusion related symptoms requiring therapeutic drainage. Conventionally, the options of therapeutic drainage of MPE include needle aspiration, and intercostal drain insertion with or without chemical pleurodesis. Needle aspiration allows quick relief of effusion and symptoms, though the volume of pleural effusion being aspirated with each attempt of needle puncture is limited to 1-1.5 litres, and repeated puncture involves risks of complications. Intercostal drain insertion will allow gradual drainage of large pleural effusion over days, but the shortcomings being the long hospitalization of at least a week, and the presence of trapped lung would preclude chemical pleurodesis for definitive fluid control. Up to 40% of MPE patients still require repeated pleural drainage procedure, even after Talc chemical pleurodesis. The much longer hospitalization period is considered unfavourable for patients with limited lifespan in terms of weeks or a few months, who would spend more time with their family. In recent few years, indwelling pleural catheter (IPC) has provided a relatively novel option of palliative MPE drainage, on an ambulatory out-patient setting. IPC has been reported to be cost-effective, in particular for patients with survival of less than 14 weeks. With the limited time span, it is important to balance between the aim of symptomatic relief and maintaining patient's quality of life. Invasive procedures and prolonged hospitalisation can cause great distress to patients. Predicted survival of patients with MPE would be important in informing the most suitable method for relieving MPE. Previous studies have identified relevant factors on prediction of survival in patients with malignant pleural effusion but so far, there is no data for Chinese patients. The LENT scoring system (pleural fluid lactate dehydrogenase, Eastern Cooperative Oncology Group performance score, neutrophil -to-lymphocyte ratio and tumour type) is a new validated prognostic score in malignant pleural effusion.

Study Type

Observational

Enrollment (Actual)

233

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Retrospective retrieval of list of subjects diagnosed to have malignant pleural effusion (MPE). Subjects diagnosed to have MPE who are under the care of Department of Medicine in Queen Mary Hospital, Hong Kong, will be invited to participate in the study

Description

Inclusion Criteria:

  • malignant pleural effusion (MPE) due to lung cancer

Exclusion Criteria:

  • workup of MPE (pleural fluid results, blood test results, or treatment history) not available
  • Patients unwilling to join study (for prospective recruitment)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Further pleural intervention
Time Frame: 3 years
Rate of fluid recurrence requiring invasive pleural interventions
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 3 years
survival of lung cancer patient with malignant pleural effusion
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Ka Yan Chiang, MBBS(HK), Queen Mary Hospital, Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

September 7, 2017

First Submitted That Met QC Criteria

September 7, 2017

First Posted (Actual)

September 8, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 16-307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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