Cancer Screening Smoking Cessation AND Respiratory Assessment

NCT06157957 | Not Yet Recruiting DMC

• 1 other identifier: Hospital de Sant Pau
• Study Type: interventional
• Target: 40,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Lung Cancer; Protection Against Malignant Lung Neoplasm (Diagnosis)

Keywords

lung cancer; tobacco cessation; respiratory assessment

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Active smokers

OTHER

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

Interventions

Lung cancer screening with low dose CT scan DIAGNOSTIC_TEST

Low dose CT scan in active smokers or ex-smokers with an age between 50 and 75 years old

Active smokers

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Sociedad Española de Neumología y Cirugía Torácica: collaborator

MeSH Terms

Conditions

Lung Neoplasms; Disease; Tobacco Use Cessation

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Juan Carlos Trujillo Reyes, MD/PHD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  STUDY DIRECTOR

Central Study Contacts

Juan Carlos Trujillo Reyes, MD/PHD

CONTACT

0034654032813; jtrujillo@santpau.cat

Luis Seijo Maceiras, MD/PHD

CONTACT

lseijo@unav.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 6, 2023
• Study Start: December 31, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1, 3 years after the beginning and at the end of the study
• Access Criteria: PI of each centre enrolled to CASSANDRA have a passwords to access to the database