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Not yet recruitingNCT06157957CASSANDRAUpdated Dec 27, 2023

Cancer Screening Smoking Cessation AND Respiratory Assessment

An interventional study of Lung cancer screening with low dose CT scan in Lung Cancer and Protection Against Malignant Lung Neoplasm (Diagnosis), sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Not yet recruiting. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-27.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40,000
Allocation
Not applicable
Ages
50 Years to 75 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Lung Cancer
  • Protection Against Malignant Lung Neoplasm (Diagnosis)

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Keywords

  • lung cancer
  • tobacco cessation
  • respiratory assessment
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 40,000 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40,000 participants (estimated)

Study arms

  • 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

Interventions

  • Diagnostic testLung 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

06

What researchers measure

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.

    Lung cancer screening

    Time frame: 0 years until 5 years

  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.

    Tobacco Cessation

    Time frame: 0 years until 5 years

  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.

    Respiratory assessment

    Time frame: 0 years until 5 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — We have a PI in each center enrolled to the project. More than 40 hospitals are enrolled to the CASSANDRA project

Supporting information: Study protocol, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06157957
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Sociedad Española de Neumología y Cirugía Torácica
Responsible party
Sponsor
First posted
Dec 6, 2023
Start date
Dec 31, 2023 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Dec 27, 2023

Study contacts

Juan Carlos Trujillo Reyes, MD/PHD
Contact
jtrujillo@santpau.cat
0034654032813
Luis Seijo Maceiras, MD/PHD
Contact
lseijo@unav.es
Juan Carlos Trujillo Reyes, MD/PHD
study director · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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