Actively Recruiting

Phase Not Applicable
Age: 45Years +
All Genders
Healthy Volunteers
NCT07465848

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

Led by Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe) · Updated on 2026-03-12

1200

Participants Needed

12

Research Sites

64 weeks

Total Duration

On this page

Sponsors

G

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

Lead Sponsor

L

Life Length SL

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Person aged 45 years or older at the time of signing the consent form.
  • For case group: Diagnosed with small-cell or non-small cell lung cancer confirmed by pathology.
  • For case group: No prior oncological treatment before sample collection.
  • For high-risk controls (Cohort A): Smoking history of at least 20 pack-years and currently smoking or quit within past 15 years.
  • For high-risk controls: No diagnosis or suspicion of lung cancer and chest CT scan within last 12 months with LUNG-RADS score of 3 or lower.
  • For low-risk controls (Cohort B): No high risk of lung cancer and no diagnosis or suspicion of lung cancer.
Not Eligible

You will not qualify if you...

  • History of any malignant tumor except those treated radically and disease-free for at least 5 years.
  • Lung cancer patient who has started oncological treatment before sample collection.
  • Biopsy, invasive procedure, or minor surgery less than 48 hours ago.
  • Major surgery less than 7 days ago.
  • Severe chronic kidney disease with glomerular filtration rate below 15 ml/min.
  • Severe liver disease classified as Child-Pugh C.
  • Active infection or infection treated less than 4 weeks ago.
  • Vulnerable populations such as minors, prisoners, pregnant women, or those unable to consent.

AI-Screening

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Trial Site Locations

Total: 12 locations

1

Hospital General Universitario de Elche

Elche, Alicante, Spain

Actively Recruiting

2

Hospital del Mar

Barcelona, Barcelona, Spain

Actively Recruiting

3

Institut Catalá D'Oncologia Badalona (ICO)

Barcelona, Barcelona, Spain

Actively Recruiting

4

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Actively Recruiting

5

Clínica Universidad de Navarra

Madrid, Madrid, Spain

Actively Recruiting

6

HM Sanchinarro/CIOCC

Madrid, Madrid, Spain

Actively Recruiting

7

Hospital Universitario 12 Octubre

Madrid, Madrid, Spain

Actively Recruiting

8

Hospital Universitario Clínico San Carlos

Madrid, Madrid, Spain

Actively Recruiting

9

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain

Actively Recruiting

10

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Actively Recruiting

11

Complejo Hospitalario de Toledo

Toledo, Toledo, Spain

Actively Recruiting

12

Hospital Universitari I Politècnic La Fe

Valencia, Valencia, Spain

Actively Recruiting

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Research Team

A

Antonio Cubillo, MD

CONTACT

P

Paloma Peinado, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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