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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Marqués 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 Fundación Jiménez Díaz
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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Dietary Supplements

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