New treatment option for Lung Cancer (Diagnosis)
Official title Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
ClinicalTrials.gov ID: NCT07465848
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Person aged 45 years or older at the time of signing the consent form.
You likely can't join if
- History of any malignant neoplasm, except for people with tumors in localized stages who have undergone radical treatment and have been disease-free...
- 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.
See the full eligibility 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...
- 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.
- History of any malignant neoplasm, except for people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Elche, Alicante, Spain
- Barcelona, Barcelona, Spain
- Santander, Cantabria, Spain
- Madrid, Madrid, Spain
- Oviedo, Principality of Asturias, Spain
- Toledo, Toledo, Spain
- Valencia, Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Elche, Alicante, Spain; Barcelona, Barcelona, Spain; Santander, Cantabria, Spain; Madrid, Madrid, Spain; Oviedo, Principality of Asturias, Spain; Toledo, Toledo, Spain and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.