Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis (PneumoTAV001)

March 9, 2026 updated by: Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe)
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain
        • Recruiting
        • Hospital General Universitario de Elche
        • Contact:
          • Javier David Benitez, MD
        • Principal Investigator:
          • Javier David Benitez, MD
    • Barcelona
      • Barcelona, Barcelona, Spain
        • Recruiting
        • Hospital del Mar
        • Contact:
          • Roberto Chalela, MD
        • Principal Investigator:
          • Roberto Chalela, MD
      • Barcelona, Barcelona, Spain
        • Recruiting
        • Institut Catalá D'Oncologia Badalona (ICO)
        • Contact:
          • Maria Saigi, MD
        • Principal Investigator:
          • Maria Saigi, MD
    • Cantabria
      • Santander, Cantabria, Spain
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
          • Marta López-Brea, MD
        • Principal Investigator:
          • María Lopez-Brea, MD
    • Madrid
      • Madrid, Madrid, Spain
        • Recruiting
        • Hospital Universitario Clínico San Carlos
        • Contact:
          • Monica Antoñanzas, MD
        • Principal Investigator:
          • Monica Antoñanzas, MD
      • Madrid, Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundacion Jimenez Diaz
        • Contact:
          • Carolina Gotera, MD
        • Principal Investigator:
          • Carolina Gotera, MD
      • Madrid, Madrid, Spain
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Luis Seijó, MD
        • Principal Investigator:
          • Luis Seijó, MD
      • Madrid, Madrid, Spain
        • Recruiting
        • HM Sanchinarro/CIOCC
        • Contact:
          • Paloma Peinado, MD
        • Principal Investigator:
          • Paloma Peinado, MD
      • Madrid, Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 Octubre
        • Contact:
          • Jon Zugazagoitia, MD
        • Principal Investigator:
          • Jon Zugazagoitia, MD
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Principal Investigator:
          • Lucía García, MD
        • Contact:
          • Lucía García, MD
    • Toledo
      • Toledo, Toledo, Spain
        • Recruiting
        • Complejo Hospitalario de Toledo
        • Contact:
          • Ana Karina Santos, MD
        • Principal Investigator:
          • Ana Karina Santos, MD
    • Valencia
      • Valencia, Valencia, Spain
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
          • Andrés Briones, MD
        • Principal Investigator:
          • Mario Briones, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Case Group
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.
Other Names:
  • Blood sample
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.
Other Names:
  • Blood sample
Other: Control Group
Cohort A (High Risk Control) and Cohort B (Low Risk Control)
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.
Other Names:
  • Blood sample
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.
Other Names:
  • Blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
To determine the algorithm's ability to detect lung cancer by analysing its sensitivity, specificity, positive and negative predictive values, and overall accuracy.
At study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe)

Collaborators

Apices Soluciones S.L.
Life Length SL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PneumoTAV001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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