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Trial record 5 of 244556 for:    Diseases

Pleural Disease: Phenotypes, Diagnostic Yield and Outcomes

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ClinicalTrials.gov Identifier: NCT03922841
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Devanand Anantham, Singapore General Hospital

Brief Summary:

Pleural disease i.e. with effusions or pneumothorax have a high disease burden to patients. This is because most patients require diagnostic and therapeutic interventions in the form of drainage and biopsies. With increasing age, the incidence of pleural disease is likely to rise with concomitant rise in pulmonary malignancy and infection.

The impact of pleural disease, especially ambulatory drainage depends not only on patient factors such as effusion size, cardiopulmonary co-morbidities and underlying aetiology. It also depends on socioeconomic factors such as ability to afford ambulatory equipment (which is not covered by Medisave), availability of care-givers and coping mechanisms.

To phenotype patients presenting to Singapore General Hospital with pleural disease and evaluate impact on outcomes of pleural interventions

This study will collect existing or prospective data that is part of standard clinical care

  • Source of the data: electronic medical record of patients (ambulatory and inpatient)
  • Data will be collected prospectively.

Condition or disease Intervention/treatment
Pleural Diseases Other: Pleural disease management

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Pleural Disease: Phenotypes, Diagnostic Yield and Outcomes
Actual Study Start Date : March 9, 2018
Estimated Primary Completion Date : March 8, 2023
Estimated Study Completion Date : March 8, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Subjects with pleural disease

The subject must meet all of the following inclusion criteria to participate in this study.

  1. Evidence of pleural disease on chest radiograph or bedside ultrasound or Computed Tomography regardless of underlying aetiology
  2. No age or gender restrictions
  3. Ability to provide informed consent
Other: Pleural disease management
History, physical examination, pleural drainage, lab/radiographic investigations




Primary Outcome Measures :
  1. Resolution of pleural disease [ Time Frame: 30 days ]
    As above



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited if they already have radiographic evidence of pleural disease.
Criteria

Inclusion Criteria:

  • The subject must meet all of the following inclusion criteria to participate in this study.

    1. Evidence of pleural disease on chest radiograph or bedside ultrasound or Computed Tomography regardless of underlying aetiology
    2. No age or gender restrictions
    3. Ability to provide informed consent

Exclusion Criteria:

  • Subjects who no radiographic evidence of pleural disease or who are unwilling/unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922841


Contacts
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Contact: Devanand Anantham, MRCP 63214700 anantham.devanand@singhealth.com.sg

Locations
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Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169856
Contact: Devanand Anantham    63214700    anantham.devanand@singhealth.com.ag   
Principal Investigator: Devanand Anantham, MRCP         
Sponsors and Collaborators
Singapore General Hospital
Investigators
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Study Chair: Devanand Anantham, MRCP Singhealth Foundation

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Responsible Party: Devanand Anantham, Senior Consultant, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03922841     History of Changes
Other Study ID Numbers: 2018/2125
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data sharing involved

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pleural Diseases
Respiratory Tract Diseases