Clinical trial · Interventional
Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
NCT07465848CI-TRIAL-00105303PneumoTAV001recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Health Adult Subjects | — | UNRESOLVED | — |
| Lung Cancer (Diagnosis) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Patient | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample collection for telomere biomarker analysis | Diagnostic Test | — | UNRESOLVED |
| Telomere biomarker analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Case Group
- interventionNames
- Diagnostic Test: Blood sample collection for telomere biomarker analysis
- Diagnostic Test: Telomere biomarker analysis
- type
- OTHER
- label
- Control Group
- description
- Cohort A (High Risk Control) and Cohort B (Low Risk Control)
- interventionNames
- Diagnostic Test: Blood sample collection for telomere biomarker analysis
- Diagnostic Test: Telomere biomarker analysis
Primary outcomes (1)
- measure
- To determine the risk of developing lung cancer, expressed as a percentage, in order to assist doctors in the diagnosis of lung cancer.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.