Pleural Effusion, MalignantNCT03276715
Prognostic Factors on Malignant Pleural Effusion
An observational study of Pleural Effusion, Malignant and Lung Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Malignant, Lung Cancer
- How many people
- 233 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2016to 1 Oct 2018
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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
Who may be able to join
- malignant pleural effusion (MPE) due to lung cancer
Who cannot join
- workup of MPE (pleural fluid results, blood test results, or treatment history) not available
- Patients unwilling to join study (for prospective recruitment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pleural Effusion, Malignant, Lung Cancer
- Keywords
- malignant pleural effusion, lung cancer
- Medical subject headings
- Pleural Effusion, Malignant, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Further pleural intervention
Rate of fluid recurrence requiring invasive pleural interventions
Measured: 3 years
Secondary outcomes (1)
Survival
survival of lung cancer patient with malignant pleural effusion
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Jun 2016
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pleural Effusion, MalignantStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- 233 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lui Mei Sze, The University of Hong Kong
- Investigators
- Ka Yan Chiang, MBBS(HK), Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276715
- Sponsor's protocol ID
- UW 16-307
- Status last verified
- Oct 2018
- First submitted
- 7 Sep 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25100651Anevlavis 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.
PubMed 24457947Bielsa 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.
PubMed 18549935Thomas 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.
PubMed 24947955Lui MM, Fitzgerald DB, Lee YC. Phenotyping malignant pleural effusions. Curr Opin Pulm Med. 2016 Jul;22(4):350-5. doi: 10.1097/MCP.0000000000000267.
PubMed 27055073Davies 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.
PubMed 22610520
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study of Prognostic Factors in Lung Cancer Patients With Malignant Pleural Effusion (MPE).
- ClinicalTrials.gov ID
- NCT03276715
- Acronym / sponsor ID
- UW 16-307
- Conditions
- Pleural Effusion, Malignant, Lung Cancer
- Keywords
- malignant pleural effusion, lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 8 Sep 2017 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- malignant pleural effusion (MPE) due to lung cancer
Key exclusion criteria (2 listed)
- workup of MPE (pleural fluid results, blood test results, or treatment history) not available
- Patients unwilling to join study (for prospective recruitment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Further pleural intervention
Time frame: 3 years
Rate of fluid recurrence requiring invasive pleural interventions
1 secondary outcome
Survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Background: PubMed 25100651Clive 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.
- Background: PubMed 24457947Anevlavis 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.
- Background: PubMed 18549935Bielsa 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.
- Background: PubMed 24947955Thomas 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.
- Background: PubMed 27055073Lui MM, Fitzgerald DB, Lee YC. Phenotyping malignant pleural effusions. Curr Opin Pulm Med. 2016 Jul;22(4):350-5. doi: 10.1097/MCP.0000000000000267.
- Background: PubMed 22610520Davies 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ka Yan Chiang, MBBS(HK) principal investigator
Queen Mary Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Effusion, Malignant and Lung Cancer, run by The University of Hong Kong at 1 site in Hong Kong.
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: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Further pleural intervention (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03276715, which also lists 6 linked publications.
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 11 Oct 2018.