NCT03276715

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
233

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Typical duration 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

June 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

2.3 years

First QC Date

September 7, 2017

Last Update Submit

October 10, 2018

Conditions

Pleural Effusion, MalignantLung Cancer

Keywords

malignant pleural effusionlung cancer

Outcome Measures

Primary Outcomes (1)

  • Further pleural intervention

    Rate of fluid recurrence requiring invasive pleural interventions

    3 years

Secondary Outcomes (1)

  • Survival

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • malignant pleural effusion (MPE) due to lung cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (6)

  • Clive AO, Kahan BC, Hooper CE, Bhatnagar R, Morley AJ, Zahan-Evans N, Bintcliffe OJ, Boshuizen RC, Fysh ET, Tobin CL, Medford AR, Harvey JE, van den Heuvel MM, Lee YC, Maskell NA. Predicting survival in malignant pleural effusion: development and validation of the LENT prognostic score. Thorax. 2014 Dec;69(12):1098-104. doi: 10.1136/thoraxjnl-2014-205285. Epub 2014 Aug 6.

    PMID: 25100651BACKGROUND

  • Anevlavis S, Kouliatsis G, Sotiriou I, Koukourakis MI, Archontogeorgis K, Karpathiou G, Giatromanolaki A, Froudarakis ME. Prognostic factors in patients presenting with pleural effusion revealing malignancy. Respiration. 2014;87(4):311-6. doi: 10.1159/000356764. Epub 2014 Jan 22.

    PMID: 24457947BACKGROUND

  • Bielsa S, Salud A, Martinez M, Esquerda A, Martin A, Rodriguez-Panadero F, Porcel JM. Prognostic significance of pleural fluid data in patients with malignant effusion. Eur J Intern Med. 2008 Jul;19(5):334-9. doi: 10.1016/j.ejim.2007.09.014. Epub 2007 Nov 8.

    PMID: 18549935BACKGROUND

  • Thomas R, Francis R, Davies HE, Lee YC. Interventional therapies for malignant pleural effusions: the present and the future. Respirology. 2014 Aug;19(6):809-22. doi: 10.1111/resp.12328. Epub 2014 Jun 19.

    PMID: 24947955BACKGROUND

  • Lui MM, Fitzgerald DB, Lee YC. Phenotyping malignant pleural effusions. Curr Opin Pulm Med. 2016 Jul;22(4):350-5. doi: 10.1097/MCP.0000000000000267.

    PMID: 27055073BACKGROUND

  • Davies HE, Mishra EK, Kahan BC, Wrightson JM, Stanton AE, Guhan A, Davies CW, Grayez J, Harrison R, Prasad A, Crosthwaite N, Lee YC, Davies RJ, Miller RF, Rahman NM. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA. 2012 Jun 13;307(22):2383-9. doi: 10.1001/jama.2012.5535.

    PMID: 22610520BACKGROUND

MeSH Terms

Conditions

Pleural Effusion, MalignantLung Neoplasms

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural EffusionPleural DiseasesRespiratory Tract DiseasesLung Diseases

Study Officials

  • Ka Yan Chiang, MBBS(HK)

    Queen Mary Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 7, 2017

First Posted

September 8, 2017

Study Start

June 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)