Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
PneumoTAV001
1 other identifier
interventional
1,200
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2025
CompletedFirst Submitted
Initial submission to the registry
December 30, 2025
CompletedFirst Posted
Study publicly available on registry
March 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 12, 2026
February 1, 2026
1.2 years
December 30, 2025
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
To evaluate the performance characteristics of the predictive algorithm, which combines clinical parameters and telomeric variables, in a cohort of cases and controls.
At study enrollment
Study Arms (2)
Case Group
OTHERControl Group
OTHERCohort A (High Risk Control) and Cohort B (Low Risk Control)
Interventions
Peripheral blood samples will be collected to measure telomere-related biomarkers that will be used for the development of a predictive algorithm.
Laboratory analysis of telomere-associated biomarkers in blood samples to generate data for the development of a predictive clinical algorithm.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2025
First Posted
March 12, 2026
Study Start
October 8, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 12, 2026
Record last verified: 2026-02