Recruiting NCT07465848
Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample collection for telomere biomarker analysis, Telomere biomarker analysis.
- Who it may be relevant to
- Registry conditions: Lung Cancer (Diagnosis), Health Adult Subjects, Patient. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test 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. - Diagnostic test Telomere biomarker analysis
Laboratory analysis of telomere-associated biomarkers in blood samples to generate data for the development of a predictive clinical algorithm.
Primary outcome measures
- To determine the risk of developing lung cancer, expressed as a percentage, in order to assist doctors in the diagnosis of lung cancer. [Time frame: At study enrollment]
Secondary outcome measures (1)
- To evaluate the performance characteristics of the predictive algorithm, which combines clinical parameters and telomeric variables, in a cohort of cases and controls. [Time frame: At study enrollment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Spain · 12 centers
- Hospital General Universitario de Elche — Elche
- Hospital del Mar — Barcelona
- Institut Catalá D'Oncologia Badalona (ICO) — Barcelona
- Hospital Universitario Marqués de Valdecilla — Santander
- Clínica Universidad de Navarra — Madrid
- HM Sanchinarro/CIOCC — Madrid
- Hospital Universitario 12 Octubre — Madrid
- Hospital Universitario Clínico San Carlos — Madrid
- … and 4 more centers
Identifiers
NCT: NCT07465848 · PneumoTAV001