Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
Recruiting now · Not applicable
Conditions studied: Lung Cancer (Diagnosis), Health Adult Subjects, Patient
In brief
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.
Key facts
- Study ID
- NCT07465848
- Run by
- Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe)
- People needed
- 1200
- Starts
- 2025-10-08
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-12
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Hospital General Universitario de Elche — Elche, Alicante, Spain (enrolling)
- Hospital del Mar — Barcelona, Barcelona, Spain (enrolling)
- Institut Catalá D'Oncologia Badalona (ICO) — Barcelona, Barcelona, Spain (enrolling)
- Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (enrolling)
- Clínica Universidad de Navarra — Madrid, Madrid, Spain (enrolling)
- HM Sanchinarro/CIOCC — Madrid, Madrid, Spain (enrolling)
- Hospital Universitario 12 Octubre — Madrid, Madrid, Spain (enrolling)
- Hospital Universitario Clínico San Carlos — Madrid, Madrid, Spain (enrolling)
- Hospital Universitario Fundación Jiménez Díaz — Madrid, Madrid, Spain (enrolling)
- Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain (enrolling)
- Complejo Hospitalario de Toledo — Toledo, Toledo, Spain (enrolling)
- Hospital Universitari I Politècnic La Fe — Valencia, Valencia, Spain (enrolling)
Full record on ClinicalTrials.gov
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