Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Dec 19, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how certain substances in the blood and tissue can help diagnose lung cancer and predict the risk of it coming back after treatment. Researchers want to find out if blood tests can accurately tell if a lung nodule (a small growth in the lung) is cancerous or not. They are also studying a specific marker in tumor tissue to see if it can identify patients at high risk for their cancer returning after surgery. Additionally, they will investigate if one of the blood tests can help detect any late recurrence of cancer.

To be eligible for this study, participants should be adults over 18 years old with a lung nodule that is suspected to be early-stage lung cancer. They should be able to have surgery at Moffitt Cancer Center if needed. However, individuals currently receiving cancer treatment, those with certain other health issues, or those who have had lung cancer in the past five years are not eligible. If you choose to participate, you will be closely monitored, and your involvement will help improve understanding and treatment of lung cancer in the future.

Gender

ALL

Eligibility 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.