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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.
Full description
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.
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.
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.
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.
4.4. Exclusion Criteria Subjects who no radiographic evidence of lung nodules or who are unwilling/unable to provide informed consent
STUDY DESIGN AND PROCEDURES/METHODOLOGY
This study will collect existing or prospective data that is part of standard clinical care
Data that will be collected
Subjects may withdraw voluntarily from participation in the study at any time. They will have standard care as indicated by the managing physician
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.
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
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
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS
The CRIB will be permitted to audit the database as needed. Source documents are from electronic medical records.
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.
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
PUBLICATIONS
Investigators will be involved in authorship depending on the degree of contribution.
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.
FUNDING and INSURANCE
This study has no funding.
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Inclusion criteria
The subject must meet all of the following inclusion criteria to participate in this study.
Exclusion criteria
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Data sourced from clinicaltrials.gov
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