Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
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.
- Condition
- Lung Cancer (Diagnosis), Health Adult Subjects, Patient
- Tested
- Blood sample collection for telomere biomarker analysis, Telomere biomarker analysis
- Sponsor
- Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe)
Who can join
- Age
- 45 years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
Inclusion 13
- Minimum age: 45 years
- Study condition: Lung Cancer (Diagnosis), Health Adult Subjects, Patient
- 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):
- 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):
- Without high risk of lung cancer according to the criteria defined in cohort A.
- No diagnosis or suspicion of lung cancer.
Exclusion 8
- 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.
Where
12 sites, 12 recruiting
Hospital del Mar
Barcelona, Barcelona, Spain
Institut Catalá D'Oncologia Badalona (ICO)
Barcelona, Barcelona, Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Clínica Universidad de Navarra
Madrid, Madrid, Spain
HM Sanchinarro/CIOCC
Madrid, Madrid, Spain
Hospital Universitario 12 Octubre
Madrid, Madrid, Spain
and 6 more sites on ClinicalTrials.gov
Contact
-
Antonio Cubillo, MD
917 56 79 97 acubillo@hmhospitales.com
-
Paloma Peinado, MD
Potential match only. Final eligibility is determined by the study team.