Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03922841 |
| Other study ID # |
2018/2125 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 9, 2018 |
| Est. completion date |
January 1, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Singapore General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
1. BACKGROUND AND RATIONALE
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.
Therefore, translating internationally accepted pleural interventions into an Asian
context, moreover a Singaporean one, is challenging.
2. HYPOTHESIS AND OBJECTIVES
Asian patients with pleural disease have unique phenotypes and outcomes from pleural
interventions
To phenotype patients presenting to Singapore General Hospital with pleural disease and
evaluate impact on outcomes of pleural interventions
3. EXPECTED RISKS AND BENEFITS
There are likely to be no benefits to subjects. They will not be subject to any novel
therapy and their clinical data will only be collected.
Risks are minimal because patients are subject to only standard therapy and existing
clinical data collected. There will be no new additional interventions, consultations or
hospital visits. They will be asked to complete validated quality of life surveys that
will be included into the clinical record.
4. STUDY POPULATION
4.1. List the number and nature of subjects to be enrolled.
Patients will only be enrolled from those who present to Singapore General Hospital
(either in an ambulatory or inpatient setting). There is no exclusion of women, children
or minorities, although clinical catchment includes mostly adult patients.
4.2. Criteria for Recruitment and Recruitment Process
Subjects will be recruited if they already have radiographic evidence of pleural
disease.
4.3. 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
4.4. Exclusion Criteria Subjects who no radiographic evidence of pleural disease or who
are unwilling/unable to provide informed consent
5. STUDY DESIGN AND PROCEDURES/METHODOLOGY
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.
- Time period: March 2018-2023
- When subject collection is complete, the data will be de-identified and kept in an
electronic database
- Only principal investigator and co-investigators will have access to collected
information.
- Data be kept for 5 years after completion of study for data analysis and manuscript
preparation
- All electronic copies of data will be destroyed at the end of the study. All manual
records if any will be shredded.
Data that will be collected
- Demographic data such as age, gender, ethnicity
- Clinical data such as co-morbidities, medication history, American Society of
Anaesthesiologists (ASA) status, smoking history, functional status (eg, ECOG)
- Radiographic data including effusion size, septations, nodularity, underlying
emphysema/fibrosis/consolidation/malignancy
- Laboratory data: Serum and pleural LDH, glucose, albumin, total protein; Full blood
counts, Renal panel, Liver Panel, Coagulation studies
- Histopathology and microbiology results
- Procedure (Pleural tap/catheter insertion/biopsy) details: designation of operator,
procedure duration, anaesthesia used, complications, volume of effusion drained,
number of biopsies taken, location of procedure, anti-microbials, pleurodesis.
- Outcome measures such as radiographic improvement, duration of pleural catheter,
quality of life using standardized measures (eg. St George's Respiratory
Questionnaire), survival, hospital re-admission, further procedures needed (eg
interventional radiology or thoracic surgery)
Subjects may withdraw voluntarily from participation in the study at any time. They will
have standard care as indicated by the managing physician
6. SAFETY MEASUREMENTS 6.1. Definitions
An adverse event (AE) is any untoward medical occurrence that occurs as a result of the
study. This will reported to CRIB.
6.2. Collecting, Recording and Reporting of Adverse Events and Serious Adverse Events to
CIRB
PI will be responsible for submitting to the approving CIRB the completed serious AE
Reporting Form within 7 calendar days after the investigator is aware of the event,
followed by a complete report within 8 additional calendar days. AE that are related
events should be reported at least annually (together with Study Status Report for
annual review).
6.3. Safety Monitoring Plan
Not applicable. Current standard investigations and treatment to be provided to all
subjects.
6.4. Complaint Handling
Complaints about the study will be escalated to the clinical Head of Department and
included in reports to the CIRB.
7. DATA ANALYSIS
7.1. Data Quality Assurance
Data collection will be done by the investigators through the clinical team managing the
patient to ensure completion and accuracy.
7.2. Data Entry and Storage
- Data will be entered and stored in a secure web application (REDCap)/password
controlled hospital computer. When subject data collection is complete, the data
will be de-identified and kept in an electronic database (password secured) for
analysis. Only investigators will have access to the data.
- There are no plans to keep any documentation of patients beyond the informed
consent forms. These will be stored in the locked department office of the
investigators.
8. SAMPLE SIZE AND STATISTICAL METHODS
8.1. Determination of Sample Size
The sample size is determined by the number of patients accrued into the database during
the study period. As this is a non-comparative study, study size calculation not
applicable.
8.2. Statistical and Analytical Plans
- Continuous safety analyses tracking for AE
- Interim Analyses of data on an annual basis
9. DIRECT ACCESS TO SOURCE DATA/DOCUMENTS
The CRIB will be permitted to audit the database as needed. Source documents are from
electronic medical records.
10. QUALITY CONTROL AND QUALITY ASSURANCE
Data collection will be done by the investigators through the clinical team managing the
patient to ensure completion and accuracy.
11. ETHICAL CONSIDERATIONS
11.1. Informed Consent
Informed consent will be sought from the patient or legal guardian (in the case of minors) by
the study investigators before any data collection is done.
11.2. Confidentiality of Data and Patient Records
- Data will be entered and stored in a secure web application (REDCap)/password controlled
hospital computer. When subject data collection is complete, the data will be
de-identified and kept in an electronic database (password secured) for analysis. Only
investigators will have access to the data.
- There are no plans to keep any documentation of patients beyond the informed consent
forms. These will be stored in the locked department office of the investigators.
