Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
Recruiting · NCT07465848 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Blood sample collection for telomere biomarker analysisTelomere biomarker analysis
What this trial is about
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.
Who can take part
Age range
45 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
12 locations listed.
- Hospital General Universitario de Elche - Elche, Alicante, Spain
- Hospital del Mar - Barcelona, Barcelona, Spain
- Institut Catalá D'Oncologia Badalona (ICO) - Barcelona, Barcelona, Spain
- Hospital Universitario Marqués de Valdecilla - Santander, Cantabria, Spain
- Clínica Universidad de Navarra - Madrid, Madrid, Spain
- HM Sanchinarro/CIOCC - Madrid, Madrid, Spain
- Hospital Universitario 12 Octubre - Madrid, Madrid, Spain
- Hospital Universitario Clínico San Carlos - Madrid, Madrid, Spain
- Hospital Universitario Fundación Jiménez Díaz - Madrid, Madrid, Spain
- Hospital Universitario Central de Asturias - Oviedo, Principality of Asturias, Spain
- Complejo Hospitalario de Toledo - Toledo, Toledo, Spain
- Hospital Universitari I Politècnic La Fe - Valencia, Valencia, Spain