Biomarkers for Diagnosis of Lung Nodules (NCT01085864) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Biomarkers for Diagnosis of Lung Nodules
United States550 participantsStarted 2010-03-17
Plain-language summary
A need exists for non-invasive testing to aid in clinical decision-making for Computerized Tomography (CT) scan detected lung nodules of indeterminate etiology. The investigators hypothesize that biomarkers detectable in blood, sputum or urine may be useful for guiding clinical decisions in the setting of CT detected lung nodules to determine which nodules are malignant and which are benign. The investigators also hypothesize that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult 18-85 years of age
. Patients referred to pulmonologists, oncologists, or thoracic surgeons for the evaluation of peripheral lung nodules found on CT scan.
. Repeat CT scans, biopsy or surgical excision are clinically indicated to determine the etiology of the nodule.
. One or more lung nodules must be between 8 mm and 30 mm in the greatest diameter.
. Patients must be fully informed of the investigational nature of the procedure and sign an informed consent.
Exclusion criteria
. Lung nodules or masses greater than 30 mm in the greatest dimension.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of biomarkers in blood, sputum or urine.
Timeframe: Baseline, 3-6 months, 12 months, 24 months, time of biopsy or surgery (if applicable), and 6 months post surgery (if applicable).