Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473870
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-16
Brief Title:
Understanding Lung Cancer Related Risk Factors and Their Impact
Sponsor:
Biocruces Bizkaia Health Research Institute
Organization:
Biocruces Bizkaia Health Research Institute
Study Overview
Official Title:
Understanding Lung Cancer Related Risk Factors and Their Impact
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUCIA
Brief Summary:
LUCIA aims to develop prediction models for the early diagnosis of lung cancer based on the identification of risk factors and deeper cellular knowledge by recording real-world data with risk assessment tools non-invasive devices and omics analysis These models will enable new clinical pathways and diagnostic workflow to be implemented to ensure early diagnosis and confirmation including classification of lung cancer subtype
Detailed Description:
Lung cancer is the leading cause of cancer death worldwide causing more deaths than breast and prostate cancer combined
The current five-year survival rate after diagnosis of all types of lung cancer in Europe is 13 112 for men and 139 for women The five-year survival rate for some types of lung cancer ranges from 6 to 7 small cell LC and 23 to 28 for non-small cell lung cancer NSCLC
Currently there are important deficiencies when it comes to achieving an adequate lung cancer screening program According to principles established in 1968 a screening program should be based on pathology that can be improved through the use of population screening
The evidence suggests two important gaps in early detection On the one hand the identification of risk factors beyond smoking and age And on the other hand the only tool for early detection that has been shown to reduce morbidity and mortality in lung cancer is chest CT a test that may not be sustainable in the long term for many healthcare systems In parallel lung cancer diagnoses among never smokers and reduced smokers are increasing rapidly suggesting that if lung cancer screening research continues focusing only on the heaviest smokers a gap will persist between the population that performs the test and the population that suffers from the disease
Evidence also suggests that people undergoing screening are not being optimally referred for follow-up or kept engaged in long-term screening
Currently there are important deficiencies when it comes to achieving an adequate lung cancer screening program The incidence in individuals without a history of smoking is increasingly higher Therefore an observational longitudinal multicenter cohort analytical study will be conducted to determine eligibility for screening based on individualized risk based on age a more detailed smoking history occupational exposure and other risk factors such as ethnicity and family history of lung cancer and the development and validation of lung cancer risk predictive models that can improve screening efficiency and reduce lung cancer morbidity and mortality
These models will allow new clinical pathways and diagnostic workflow to be implemented to ensure rapid diagnosis and confirmation including lung cancer subtype classification
The study consists of collecting data from participants in 4 visits over two years During each visit the clinical evaluation will be carried out which will consist of the collection of sociodemographic data and clinical history physical examination concomitant medication collection of exposure data and guide symptoms Quality of Life questionnaires and geolocation In addition the following tests will be performed low-dose computed tomography LDCT blood tests genomic analysis and tests with new non-invasive devices spectrometry on card SPOC breath analyzer BAN and broad-spectrum biomarker sensor patch WBSP With all this the aim is to develop and validate new tests based on new non-invasive and easy-to-use technologies that allow for the implementation of more efficient acceptable and equitable population screening programs in the near future
The completion of this project will allow to provide data that can be used to better understand and discover new risk factors for suffering from lung cancer and therefore improve the management of the disease
Furthermore this study will favor the reduction of long-term morbidity and mortality from lung cancer and will allow the future implementation of a lung cancer program
The current five-year survival rate after diagnosis of all types of lung cancer in Europe is 13 112 for men and 139 for women The five-year survival rate for some types of lung cancer ranges from 6 to 7 small cell LC and 23 to 28 for non-small cell lung cancer NSCLC
Currently there are important deficiencies when it comes to achieving an adequate lung cancer screening program According to principles established in 1968 a screening program should be based on pathology that can be improved through the use of population screening
The evidence suggests two important gaps in early detection On the one hand the identification of risk factors beyond smoking and age And on the other hand the only tool for early detection that has been shown to reduce morbidity and mortality in lung cancer is chest CT a test that may not be sustainable in the long term for many healthcare systems In parallel lung cancer diagnoses among never smokers and reduced smokers are increasing rapidly suggesting that if lung cancer screening research continues focusing only on the heaviest smokers a gap will persist between the population that performs the test and the population that suffers from the disease
Evidence also suggests that people undergoing screening are not being optimally referred for follow-up or kept engaged in long-term screening
Currently there are important deficiencies when it comes to achieving an adequate lung cancer screening program The incidence in individuals without a history of smoking is increasingly higher Therefore an observational longitudinal multicenter cohort analytical study will be conducted to determine eligibility for screening based on individualized risk based on age a more detailed smoking history occupational exposure and other risk factors such as ethnicity and family history of lung cancer and the development and validation of lung cancer risk predictive models that can improve screening efficiency and reduce lung cancer morbidity and mortality
These models will allow new clinical pathways and diagnostic workflow to be implemented to ensure rapid diagnosis and confirmation including lung cancer subtype classification
The study consists of collecting data from participants in 4 visits over two years During each visit the clinical evaluation will be carried out which will consist of the collection of sociodemographic data and clinical history physical examination concomitant medication collection of exposure data and guide symptoms Quality of Life questionnaires and geolocation In addition the following tests will be performed low-dose computed tomography LDCT blood tests genomic analysis and tests with new non-invasive devices spectrometry on card SPOC breath analyzer BAN and broad-spectrum biomarker sensor patch WBSP With all this the aim is to develop and validate new tests based on new non-invasive and easy-to-use technologies that allow for the implementation of more efficient acceptable and equitable population screening programs in the near future
The completion of this project will allow to provide data that can be used to better understand and discover new risk factors for suffering from lung cancer and therefore improve the management of the disease
Furthermore this study will favor the reduction of long-term morbidity and mortality from lung cancer and will allow the future implementation of a lung cancer program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None