Ireland
--:--IST
Recruiting Not applicable

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

NCT07465848 · tracked via the Priya Life Science Spain tracker
Sponsor
Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe)
Phase
Not applicable
Started
2025-10-08
Last updated
2026-03-12

Condition(s) studied

Lung Cancer (Diagnosis)Health Adult SubjectsPatient

Investigational drug(s) / intervention(s)

Blood sample collection for telomere biomarker analysisTelomere biomarker analysis

Blood sample collection for telomere biomarker analysis: Peripheral blood samples will be collected to measure telomere-related biomarkers that will be used for the development of a predictive algorithm.

Telomere biomarker analysis: Laboratory analysis of telomere-associated biomarkers in blood samples to generate data for the development of a predictive clinical algorithm.

Study summary

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.

Eligibility

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • To determine the risk of developing lung cancer, expressed as a percentage, in order to assist doctors in the diagnosis of lung cancer. — At study enrollment

Trial sites (12)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07465848 on ClinicalTrials.gov ↗ ← All trials in Spain