Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
Recruiting
N/AInterventional Study
Lung Cancer (Diagnosis)Health Adult SubjectsPatient
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
1,200 (estimated)
Sponsor
Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe) · Other
Who this trial is looking for
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This research is a clinical performance study of in vitro diagnostic device (IVD), a prospective, multicentre, open-label, case-control clinical investigation aimed at constructing a predictive model that allows results to be classified as positive or negative in relation to the probability of having lung cancer.
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Eligibility Criteria
Inclusion Criteria:
Case Group:
* Person aged 45 years or older at the time of signing the consent form.
* Person with a current anatomopathologically confirmed diagnosis of small-cell or non-small cell lung cancer.
* Not having received any oncological treatment prior to sample collection (surger…
Inclusion Criteria:
Case Group:
* Person aged 45 years or older at the time of signing the consent form.
* Person with a current anatomopathologically confirmed diagnosis of small-cell or non-small cell lung cancer.
* Not having received any oncological treatment prior to sample collection (surgery, radiotherapy, or systemic treatment with chemotherapy or immunotherapy).
Control Group:
Cohort A (High risk controls):
* Person aged 45 years or older at the time of signing the consent form.
* High risk of lung cancer, defined as having a smoking history of at least 20 pack-year and currently smoking or having quit within the past 15 years.
* No diagnosis or suspicion of lung cancer. Asymptomatic individuals who have undergone a chest computed tomography (CT) scan for lung cancer screening within the 12 months prior to signing the informed consent and as part of routine clinical practice, with a LUNG-RADS score of 3 or lower, will be included.
Cohort B (Low-risk controls):
* Person aged 45 years or older at the time of signing the consent form.
* Without high risk of lung cancer according to the criteria defined in cohort A.
* No diagnosis or suspicion of lung cancer.
Exclusion Criteria:
* History of any malignant neoplasm, except for subjects with tumors in localized stages who have undergone radical treatment and have been disease-free for at least five years.
* Patient diagnosed with lung cancer who has already started oncological treatment before sample collection.
* Patient who has undergone a biopsy or any invasive procedure or minor surgery less than 48 hours ago.
* Patient who has undergone major surgery less than 7 days ago.
* Patient with severe chronic kidney disease, defined as a glomerular filtration rate below 15 ml/min.
* Patient with severe liver disease, defined as Child-Pugh C.
* Active infection, or treated less than 4 weeks ago.
* Vulnerable population, for example, minors, prisoners, pregnant women, adults physically or mentally incapable of giving consent.
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