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NCT Number: NCT06157957

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

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Key information

Conditions

Lung Cancer Behavior Disease Health Behavior Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Protection Against Malignant Lung Neoplasm (Diagnosis) Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Tobacco Use Cessation

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Carlos Trujillo Reyes, MD/PHD

CONTACT

[email protected]

0034654032813

Luis Seijo Maceiras, MD/PHD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Sociedad Española de Neumología y Cirugía Torácica

Registry information

Official study title

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

Acronym: CASSANDRA

Important dates

Study start
2023
Primary completion
2024
Study completion
2028
First posted
Dec 6, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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