NCT07465848Recruiting
Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1200 (estimated)
- First submitted
- 30 Dec 2025
- Start date
- 8 Oct 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe)
- Diseases
- Lung cancer
- NCT number
- NCT07465848
What you commit to
- Study type: Interventional
- Planned participants: 1200
- From 8 Oct 2025 to the primary completion date, 31 Dec 2026
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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 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.
Other
- Vulnerable population, for example, minors, prisoners, pregnant women, adults physically or mentally incapable of giving consent.
Who the study is looking for
- 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.
Age in the registry: 45 years to - · Sex: All · Accepts healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Institut Catalá D'Oncologia Badalona (ICO) Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital General Universitario de Elche Coordinator of this site? Confirm its status | Elche | Spain | Recruiting |
| Hospital Universitario 12 Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| HM Sanchinarro/CIOCC Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Complejo Hospitalario de Toledo Coordinator of this site? Confirm its status | Toledo | Spain | Recruiting |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.