Cancer Screening Smoking Cessation AND Respiratory Assessment

Lung Cancer Clinical Trial

— CASSANDRA  

Official title:

Lung Cancer Screening Pilot Programme: Cancer Screening Smoking Cessation AND Respiratory Assessment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06157957
• Other study ID #: Hospital de Sant Pau
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 31, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Juan Carlos Trujillo Reyes, MD/PHD
• Phone: 0034654032813
• Email: jtrujillo[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

CASSANDRA aims to be the first lung cancer screening pilot project in Spain. A project to assess the feasibility of implementation as well as to look for models that allow a better selection of the cases to be screened.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Diagnostic Test:
• Lung cancer screening with low dose CT scan
Low dose CT scan in active smokers or ex-smokers with an age between 50 and 75 years old

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Sociedad Española de Neumología y Cirugía Torácica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Lung cancer screening	0 years until 5 years
Primary	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.	Tobacco Cessation	0 years until 5 years
Primary	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.	Respiratory assessment	0 years until 5 years