Actively Recruiting
Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
Led by Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe) · Updated on 2026-03-12
1200
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe)
Lead Sponsor
L
Life Length SL
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multicenter clinical performance study to evaluate a new in vitro diagnostic device that uses telomere measurement technology to help diagnose lung cancer. The study aims to build a predictive model that classifies results as positive or negative based on the likelihood of having lung cancer. This investigation includes both high-risk and low-risk control groups as well as patients with confirmed lung cancer to better understand the device's diagnostic potential. Participants will be grouped into cases with lung cancer and controls classified as high risk or low risk for lung cancer. The study involves collecting peripheral blood samples to analyze telomere-related biomarkers. These biomarkers, combined with clinical parameters, will be used to develop a predictive algorithm that aids doctors in diagnosing lung cancer. The study is open-label and non-randomized, taking place across multiple centers. Study participants will undergo blood sample collection at enrollment for telomere biomarker analysis. Researchers will assess the risk percentage of developing lung cancer and evaluate the performance of the predictive algorithm using the collected data. The primary outcome is determining lung cancer risk at enrollment, with secondary outcomes focusing on algorithm performance. The study involves adults aged 45 years and older and includes ongoing monitoring of participant health status as part of the diagnostic evaluation process.
CONDITIONS
Brief Title
Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Person aged 45 years or older at the time of signing the consent form.
- For Case Group: Diagnosed with small-cell or non-small cell lung cancer confirmed by pathology.
- For Case Group: No prior oncological treatment before sample collection.
- For Control Group Cohort A (High risk controls): Smoking history of at least 20 pack-years and currently smoking or quit within past 15 years.
- For Control Group Cohort A: No diagnosis or suspicion of lung cancer and recent chest CT scan with LUNG-RADS score of 3 or lower.
- For Control Group Cohort B (Low risk controls): No high risk for lung cancer and no diagnosis or suspicion of lung cancer.
You will not qualify if you...
- History of any malignant tumor except those treated radically and disease-free for at least five years.
- Lung cancer patients who have started oncological treatment before sample collection.
- Recent biopsy, invasive procedure, or minor surgery within 48 hours.
- Major surgery within the last 7 days.
- Severe chronic kidney disease with glomerular filtration rate below 15 ml/min.
- Severe liver disease defined as Child-Pugh C.
- Active infection or infection treated within the last 4 weeks.
- Vulnerable populations including minors, prisoners, pregnant women, or adults unable to give consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At study enrollment
Participants provide blood samples for telomere biomarker analysis to assist in lung cancer diagnosis.
1 visit (in-person)
Trial Site Locations
Total: 12 locations
1
Hospital General Universitario de Elche
Elche, Alicante, Spain
Actively Recruiting
2
Hospital del Mar
Barcelona, Barcelona, Spain
Actively Recruiting
3
Institut Catalá D'Oncologia Badalona (ICO)
Barcelona, Barcelona, Spain
Actively Recruiting
4
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Actively Recruiting
5
Clínica Universidad de Navarra
Madrid, Madrid, Spain
Actively Recruiting
6
HM Sanchinarro/CIOCC
Madrid, Madrid, Spain
Actively Recruiting
7
Hospital Universitario 12 Octubre
Madrid, Madrid, Spain
Actively Recruiting
8
Hospital Universitario Clínico San Carlos
Madrid, Madrid, Spain
Actively Recruiting
9
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Actively Recruiting
10
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Actively Recruiting
11
Complejo Hospitalario de Toledo
Toledo, Toledo, Spain
Actively Recruiting
12
Hospital Universitari I Politècnic La Fe
Valencia, Valencia, Spain
Actively Recruiting
Research Team
A
Antonio Cubillo, MD
P
Paloma Peinado, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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