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: Not yet recruiting
• Conditions: Lung Cancer; Protection Against Malignant Lung Neoplasm (Diagnosis)
• Intervention / Treatment: Diagnostic test: Lung cancer screening with low dose CT scan

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40000
• 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: Yes

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)

Number of Arms

1

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	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

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.	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.	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.	Respiratory assessment	0 years until 5 years

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Sociedad Española de Neumología y Cirugía Torácica
• 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): December 31, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 24, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: lung cancer; tobacco cessation; respiratory assessment
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Hospital de Sant Pau

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We have a PI in each center enrolled to the project. More than 40 hospitals are enrolled to the CASSANDRA project
• IPD Sharing Time Frame: 1, 3 years after the beginning and at the end of the study
• IPD Sharing Access Criteria: PI of each centre enrolled to CASSANDRA have a passwords to access to the database
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No