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Cancer Screening Smoking Cessation AND Respiratory Assessment

NCT ID: NCT06157957

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-31

Study Completion Date

2028-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Lung Cancer Protection Against Malignant Lung Neoplasm (Diagnosis)

Keywords

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lung cancer tobacco cessation respiratory assessment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Lung cancer screening with low dose CT scan

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sociedad Española de Neumología y Cirugía Torácica

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan Carlos Trujillo Reyes, MD/PHD

Role: STUDY_DIRECTOR

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

Central Contacts

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Juan Carlos Trujillo Reyes, MD/PHD

Role: CONTACT

Phone: 0034654032813

Email: [email protected]

Luis Seijo Maceiras, MD/PHD

Role: CONTACT

Email: [email protected]

Other Identifiers

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Hospital de Sant Pau

Identifier Type: -

Identifier Source: org_study_id