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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

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital del Mar
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Institut Catalá D'Oncologia Badalona (ICO)
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BarcelonaSpainRecruiting
Hospital General Universitario de Elche
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ElcheSpainRecruiting
Hospital Universitario 12 Octubre
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MadridSpainRecruiting
HM Sanchinarro/CIOCC
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Hospital Universitario Clínico San Carlos
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MadridSpainRecruiting
Clinica Universidad de Navarra
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MadridSpainRecruiting
Hospital Universitario Central De Asturias
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OviedoSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Complejo Hospitalario de Toledo
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ToledoSpainRecruiting
Hospital Universitari i Politécnic La Fe
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ValenciaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.