Evaluating biomarkers for diagnosing and monitoring lung cancer
Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
This study is testing if certain blood and tissue markers can help doctors better diagnose lung cancer and identify patients at risk for recurrence after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT05665504 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on assessing blood and tissue biomarkers to improve the diagnosis and risk stratification of lung cancer. Investigators will evaluate the accuracy of blood biomarkers in distinguishing between cancerous and benign lung nodules. Additionally, they will analyze tumor tissue biomarkers to identify patients at high risk for recurrence after lung cancer surgery. The study also aims to determine if a specific blood-based biomarker can detect late recurrences of cancer.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with potentially resectable lung nodules suspected to be clinically node-negative lung cancer.
Not a fit: Patients currently undergoing cancer treatment or with uncontrolled intercurrent illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and better monitoring of lung cancer, ultimately improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using biomarkers for lung cancer diagnosis and monitoring, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer \[clinical stage IA-IB (cT1a-T2aN0), \<4cm diameter\]. * If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center. * If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center. * \>18 years old, male or female. * ECOG performance status 0-1. * Agree to participate in the follow-up protocol. * Any suspected primary lung cancer cell type (except a suspected typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma). * Ability to understand and the willingness to sign a written, informed consent document. Exclusion Criteria: * Participants who are actively receiving any cancer treatment. * Participants with uncontrolled intercurrent illness. * Prior lung cancer within 5 years. * Current active other major cancer except non-melanoma skin cancer. * Patients with pure ground glass opacities (nodules) or hilar masses. * Suspected typical carcinoid cell type (well-differentiated neuroendocrine carcinoma). * Metastatic nodule (suspected) in the lung from an extrapulmonary cancer. * Patient unable to provide informed consent. * Prisoner or incarcerated individual. * For surgical patients, a R1 or R2 resection.
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Lary A Robinson, MD — Moffitt Cancer Center
- Study coordinator: Brianna Aponte
- Email: Brianna.Aponte@moffitt.org
- Phone: 813-745-0787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.