Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03922828 |
| Other study ID # |
2018/2596 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 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
Lung cancer is one of the most common cancers in the Singapore population, being the 2nd most
commonly diagnosed cancer amongst males and 3rd most commonly diagnosed cancer amongst
females. Pulmonologists, oncologists and thoracic surgeons are often consulted for the
evaluation of imaging-identified pulmonary nodules. These may have been identified either
incidentally or through screening. The majority of these are indeterminate and definitive
investigation with biopsy or resection is invasive and not without risk. Hence, current
consensus guidelines adopt a largely expectant strategy in the management of these
indeterminate pulmonary nodules.
There is substantial evidence that lung cancer in Asians may be unique with multiple driver
mutations, lower age of presentation and may be independent of tobacco exposure. In addition,
there are guidelines that recommend that the management of lung nodules in Asia should
account for these differences. However, the evidence for alternative recommendations is
lacking.
The aim of the study will be to identify radiological and clinical predictors that can
improve the diagnosis of lung nodules. These predictors may help build a model for lung
nodule evaluation and surveillance.
Prospective database of subjects meeting all of the following inclusion criteria to
participate in this study.
1. Evidence of lung nodule on chest radiograph or Computed Tomography regardless of
underlying aetiology
2. Age ³ 21 years old
3. Ability to provide informed consent This study will collect existing or prospective data
that is part of standard clinical care from the electronic medical record of patients
(ambulatory and inpatient from May 2018-2023.
Description:
1. BACKGROUND AND RATIONALE
Lung cancer is one of the most common cancers in the Singapore population, being the 2nd
most commonly diagnosed cancer amongst males and 3rd most commonly diagnosed cancer
amongst females. Pulmonologists, oncologists and thoracic surgeons are often consulted
for the evaluation of imaging-identified pulmonary nodules. These may have been
identified either incidentally or through screening. The majority of these are
indeterminate and definitive investigation with biopsy or resection is invasive and not
without risk. Hence, current consensus guidelines adopt a largely expectant strategy in
the management of these indeterminate pulmonary nodules.
There is substantial evidence that lung cancer in Asians may be unique with multiple
driver mutations, lower age of presentation and may be independent of tobacco exposure.
In addition, there are guidelines that recommend that the management of lung nodules in
Asia should account for these differences. However, the evidence for alternative
recommendations is lacking.
2. HYPOTHESIS AND OBJECTIVES
The aim of the study will be to identify radiological and clinical predictors that can
improve the diagnosis of lung nodules. These predictors may help build a model for lung
nodule evaluation and surveillance.
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/radiological data will only be collected.
Risks are minimal because patients are subject to only standard diagnostic work-up 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,
National Cancer Centre, National Heart Centre, Changi General Hospital and Sengkang
General Hospital (either in an ambulatory or inpatient setting). There is no exclusion
of women or minorities. Children are excluded because lung nodule detection in them is
rare and the pathological processes, as well as clinical considerations are different.
4.2. Criteria for Recruitment and Recruitment Process
Subjects will be recruited if they already have radiographic evidence of a lung nodule.
4.3. Inclusion Criteria
The subject must meet all of the following inclusion criteria to participate in this
study.
1. Evidence of lung nodule on chest radiograph or Computed Tomography regardless of
underlying aetiology
2. Age > 21 years old
3. Ability to provide informed consent
4.4. Exclusion Criteria Subjects who no radiographic evidence of lung nodules 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: May 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 6 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, ambulatory/inpatient setting
- Clinical data including co-morbidities, medication history, American Society of
Anaesthesiologists (ASA) status, smoking history, functional status (eg ECOG),
- Risk factors such as BMI, exercise intensity, previous malignancy, radiation
exposure, 2nd hand cigarette exposure, Family history of cancer,
asbestos/environmental exposure
- Radiographic data including nodule size, location and characteristics (borders,
density, calcification, cavitation thickness), fibrosis, adenopathy
- Laboratory data including LDH, glucose, albumin, total protein; Full blood counts,
Renal panel, Liver Panel, Coagulation studies
- Histopathology and microbiology results
- Procedure details: designation of operator, procedure duration, anaesthesia used,
complications, number of biopsies taken, size of specimen, location of procedure,
use of anti-microbials
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.
12. PUBLICATIONS
Investigators will be involved in authorship depending on the degree of contribution.
13. RETENTION OF STUDY DOCUMENTS
Study documents will be retained for 6 years after the end of the study in a locked
department office and hospital computer that is password protected.
14. FUNDING and INSURANCE
This study has no funding.
