Pleural Effusion, MalignantNCT04670562
Longitudinal Follow up of Patients With Pleural Effusion
An observational study of Pleural Effusion, Malignant and Prognosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This study aims to evaluate the clinical course of patients diagnosed with pleural effusion and determine various clinical factors and biomarkers associated that can predict the diagnosis and clinical outcome and prognosis of patients with pleural effusion due to specific causes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pleural Effusion, Malignant, Prognosis
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2021to 31 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who presented with pleural effusion and undergo diagnostic/therapeutic thoracentesis
Who may be able to join
- Patients presented with pleural effusion
- Patients who undergo thoracentesis and fluid analysis for diagnosis and management
Who cannot join
- Patients who refuse to be enrolled
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Yeon Wook Kim, Professor, 82-10-7497-5586, kimyw@snu.ac.kr
About this study
Official title: Longitudinal Follow up of Patients With Pleural Effusion in South Korea
This study aims to evaluate the clinical course of patients diagnosed with pleural effusion and determine various clinical factors and biomarkers associated that can predict the diagnosis and clinical outcome and prognosis of patients with pleural effusion due to specific causes.
Read the detailed description
Patients who presented to Seoul National University Bundang Hospital with pleural effusion would be recruited. Pleural fluid and blood samples would be collected. All patients will receive routine diagnostic procedures and medical care and treatments according to the diagnosis; the original cancer if diagnosed with malignant effusion, and managements for pleural effusion control. Patients would be observed for the clinical course and prognosis up to 3 years without any interventions caused by this study.
- Conditions
- Pleural Effusion, Malignant, Prognosis
- Medical subject headings
- Pleural Effusion, Malignant
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality
Measured: From date of diagnosis of malignant pleural effusion until the date of death, assessed up to 36 months.
Secondary outcomes (1)
Disease progression
Progression of original malignancy or new metastasis occured
Measured: From date of diagnosis of malignant pleural effusion until the date of first documented disease progression, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Mar 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural Effusion, MalignantStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeon Wook Kim, Professor, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670562
- Sponsor's protocol ID
- B-2006/618-311
- Status last verified
- Apr 2022
- First submitted
- 9 Dec 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Follow up of Patients With Pleural Effusion in South Korea
- ClinicalTrials.gov ID
- NCT04670562
- Acronym / sponsor ID
- B-2006/618-311
- Conditions
- Pleural Effusion, Malignant, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Dec 2020 (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.
This study aims to evaluate the clinical course of patients diagnosed with pleural effusion and determine various clinical factors and biomarkers associated that can predict the diagnosis and clinical outcome and prognosis of patients with pleural effusion due to specific causes.
Detailed description
Patients who presented to Seoul National University Bundang Hospital with pleural effusion would be recruited. Pleural fluid and blood samples would be collected. All patients will receive routine diagnostic procedures and medical care and treatments according to the diagnosis; the original cancer if diagnosed with malignant effusion, and managements for pleural effusion control. Patients would be observed for the clinical course and prognosis up to 3 years without any interventions caused by this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who presented with pleural effusion and undergo diagnostic/therapeutic thoracentesis
Key inclusion criteria (2 listed)
- Patients presented with pleural effusion
- Patients who undergo thoracentesis and fluid analysis for diagnosis and management
Key exclusion criteria (1 listed)
- Patients who refuse to be enrolled
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
Mortality
Time frame: From date of diagnosis of malignant pleural effusion until the date of death, assessed up to 36 months.
Mortality
1 secondary outcome
Disease progression
Time frame: From date of diagnosis of malignant pleural effusion until the date of first documented disease progression, assessed up to 36 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: Undecided
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UNC Pleural Fluid Registry
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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.
Yeon Wook Kim, Professor principal investigator
Seoul National University Bundang Hospital
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 Prognosis, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Jun 2022. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeon Wook Kim, Professor (82-10-7497-5586, kimyw@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From date of diagnosis of malignant pleural effusion until the date of death, assessed up to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2022.