Cancer Screening Smoking Cessation AND Respiratory Assessment (CASSANDRA)
Lung Cancer Screening Pilot Programme: Cancer Screening Smoking Cessation AND Respiratory Assessment
The CASSANDRA project (Cancer Screening, Smoking Cessation, AND Respiratory Assessment) is a project led by SEPAR whose main coordinators are Dr. Luis Seijo, a pulmonologist at the Clínica Universitaria de Navarra, and Dr. Juan Carlos Trujillo-Reyes, a thoracic surgeon at the Hospital de la Santa Creu I Sant Pau and Coordinator of the Thoracic Oncology Area, in addition to the collaboration of a large number of professionals with expertise in lung cancer screening.
Despite its proven efficacy, Spain does not yet have a unified lung cancer screening protocol. The aim of the CASSANDRA project is to initiate a national screening program that can join forces with existing smoking cessation programs in Spain, which have proven to be insufficient in reducing the number of people affected by lung cancer.
CASSANDRA aims to analyze the feasibility of implementing a lung cancer screening program in Spain implemented in the public health system and carry out a cost-effectiveness analysis
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Juan Carlos Trujillo Reyes, MD/PHD
- Phone Number: 0034654032813
- Email: jtrujillo@santpau.cat
Study Contact Backup
- Name: Luis Seijo Maceiras, MD/PHD
- Email: lseijo@unav.es
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 50-75 years active smoker with cumulative dose of >20 packets/year
- Age 50-75 years ex-smoker less than 15 years old with cumulative dose of > 20 packets/year
Exclusion Criteria:
- Pre-existing or new-onset comorbidities that, in the opinion of the coordinator, prevent surgical resection if lung cancer is found on low dose computed tomography (LDCT) scan, for example, severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume at one second (FEV1) < 30%.
- Inability to sign the informed consent or collaborate with the CT scan.
- Performing a chest CT for any reason in the previous year or planned CT for any reason in the next 3 months.
- Subjects with a history of any cancer (except non-melanoma skin cancer) in the 5 years prior to inclusion in the screening program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Active smokers
We do a CT scan in active smokers and ex-smokers plus an spirometry combined to a tobacco cessation programme in active smokers
|
Low dose CT scan in active smokers or ex-smokers with an age between 50 and 75 years old
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of lung cancer in early stage in a high risk population during a lung cancer screening programme. We measure this outcome depending on the CT results.
Time Frame: 0 years until 5 years
|
Lung cancer screening
|
0 years until 5 years
|
|
The number of patients who quit smoking during a lung cancer screening program. We will measure this parameter by recording smoking cessation during the 5 years.
Time Frame: 0 years until 5 years
|
Tobacco Cessation
|
0 years until 5 years
|
|
The number of patients who present other diseases associated with smoking such as emphysema, COPD or coronary pathology. We will measure this parameter by means of spirometry and CT scan.
Time Frame: 0 years until 5 years
|
Respiratory assessment
|
0 years until 5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Juan Carlos Trujillo Reyes, MD/PHD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hospital de Sant Pau
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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