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Lung Cancer (Diagnosis)PneumoTAV001NCT07465848

Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis

A study testing Blood sample collection for telomere biomarker analysis and Telomere biomarker analysis in people with Lung Cancer (Diagnosis) and Health Adult Subjects, run by Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe) at 12 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
What is being tested?
Blood sample collection for telomere biomarker analysis and Telomere biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
12 sitesSpain
Study dates
8 Oct 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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):
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Antonio Cubillo, MD contact

917 56 79 97

acubillo@hmhospitales.com

Paloma Peinado, MD contact

ppeinado@hmhospitales.com

12 sites in 1 country

Spain12 sites, 12 recruiting

  • Hospital del Mar

    Barcelona, Barcelona

    Roberto Chalela, MD

    Roberto Chalela, MD

    Recruiting

  • Institut Catalá D'Oncologia Badalona (ICO)

    Barcelona, Barcelona

    Maria Saigi, MD

    Maria Saigi, MD

    Recruiting

  • Hospital General Universitario de Elche

    Elche, Alicante

    Javier David Benítez, MD

    Javier David Benítez, MD

    Recruiting

  • Clínica Universidad de Navarra

    Madrid, Madrid

    Luis Seijó, MD

    Luis Seijó, MD

    Recruiting

  • HM Sanchinarro/CIOCC

    Madrid, Madrid

    Paloma Peinado, MD

    Paloma Peinado, MD

    Recruiting

  • Hospital Universitario 12 Octubre

    Madrid, Madrid

    Jon Zugazagoitia, MD

    Jon Zugazagoitia, MD

    Recruiting

  • Hospital Universitario Clínico San Carlos

    Madrid, Madrid

    Mónica Antoñanzas, MD

    Mónica Antoñanzas, MD

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid

    Carolina Gotera, MD

    Carolina Gotera, MD

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias

    Lucía García, MD

    Lucía García, MD

    Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria

    Marta López-Brea, MD

    María Lopez-Brea, MD

    Recruiting

  • Complejo Hospitalario de Toledo

    Toledo, Toledo

    Ana Karina Santos, MD

    Ana Karina Santos, MD

    Recruiting

  • Hospital Universitari I Politècnic La Fe

    Valencia, Valencia

    Andrés Briones, MD

    Mario Briones, MD

    Recruiting

Other trials in Spain

About this study

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.

Being tested
Blood sample collection for telomere biomarker analysis, Telomere biomarker analysis
Medical subject headings
Lung Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sample collection for telomere biomarker analysisDiagnostic test

    Also called Blood sample

    Peripheral blood samples will be collected to measure telomere-related biomarkers that will be used for the development of a predictive algorithm.

  • Telomere biomarker analysisDiagnostic test

    Also called Blood sample

    Laboratory analysis of telomere-associated biomarkers in blood samples to generate data for the development of a predictive clinical algorithm.

Study groups in NCT07465848
Study groupRoleWhat they receive
Case GroupOtherNot described
Receives: Diagnostic Test: Blood sample collection for telomere biomarker analysis; Diagnostic Test: Telomere biomarker analysis
Control GroupOtherCohort A (High Risk Control) and Cohort B (Low Risk Control)
Receives: Diagnostic Test: Blood sample collection for telomere biomarker analysis; Diagnostic Test: Telomere biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the risk of developing lung cancer, expressed as a percentage, in order to assist doctors in the diagnosis of lung cancer.

    Measured: At study enrollment

Secondary outcomes (1)

  1. To evaluate the performance characteristics of the predictive algorithm, which combines clinical parameters and telomeric variables, in a cohort of cases and controls.

    To determine the algorithm's ability to detect lung cancer by analysing its sensitivity, specificity, positive and negative predictive values, and overall accuracy.

    Measured: At study enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start8 Oct 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07465848
Sponsor's protocol ID
PneumoTAV001
Acronym
PneumoTAV001
Status last verified
Feb 2026
First submitted
30 Dec 2025
Last updated
12 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample collection for telomere biomarker analysis and Telomere biomarker analysis in people with Lung Cancer (Diagnosis) and Health Adult Subjects, run by Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe) at 12 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Antonio Cubillo, MD (917 56 79 97, acubillo@hmhospitales.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07465848.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.

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