Using a blood telomere test to help diagnose lung cancer

Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis

This research will test whether a blood telomere test can tell who has lung cancer among adults 45 and older by comparing newly diagnosed, untreated patients to high‑ and low‑risk controls.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe) (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 12 sites (Elche, Alicante and 11 other locations)
• Trial ID: NCT07465848 on ClinicalTrials.gov

What this trial studies

This prospective, multicentre, open‑label case‑control clinical performance investigation collects blood samples from adults 45 and older at several hospitals in Spain to measure telomere-based biomarkers. Participants include treatment‑naive, pathologically confirmed lung cancer patients and two control groups: high‑risk smokers and low‑risk screened individuals. Telomere analysis in the lab will be used to build a predictive model that classifies results as positive or negative for the probability of lung cancer. The primary aim is to see if the telomere test can distinguish cancer cases from controls and serve as a noninvasive diagnostic aid.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 or older who are either newly diagnosed, treatment‑naive lung cancer patients or high‑risk (≥20 pack‑year smoking history) or low‑risk controls who can attend participating Spanish hospitals.

Not a fit: People under 45, those who have already started cancer treatment, or those with cancers other than lung cancer are unlikely to receive direct benefit from participation.

Why it matters

Potential benefit: If successful, the telomere blood test could help detect lung cancer noninvasively and reduce unnecessary scans or invasive diagnostic procedures.

How similar studies have performed: Using telomere measurements for lung cancer diagnosis is relatively novel: small studies have shown associations but this specific diagnostic application is not yet proven.

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 (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 this trial is running

Elche, Alicante and 11 other locations

• Hospital General Universitario de Elche — Elche, Alicante, Spain (Recruiting)
• Hospital del Mar — Barcelona, Barcelona, Spain (Recruiting)
• Institut Catalá D'Oncologia Badalona (ICO) — Barcelona, Barcelona, Spain (Recruiting)
• Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain (Recruiting)
• Clínica Universidad de Navarra — Madrid, Madrid, Spain (Recruiting)
• HM Sanchinarro/CIOCC — Madrid, Madrid, Spain (Recruiting)
• Hospital Universitario 12 Octubre — Madrid, Madrid, Spain (Recruiting)
• Hospital Universitario Clínico San Carlos — Madrid, Madrid, Spain (Recruiting)
• Hospital Universitario Fundación Jiménez Díaz — Madrid, Madrid, Spain (Recruiting)
• Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain (Recruiting)
• Complejo Hospitalario de Toledo — Toledo, Toledo, Spain (Recruiting)
• Hospital Universitari I Politècnic La Fe — Valencia, Valencia, Spain (Recruiting)

Study contacts

• Study coordinator: Antonio Cubillo, MD

Conditions Lung Cancer; Health Adult Subjects; Patient