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

Recruiting now

Conditions studied: Lung; Node, Adenocarcinoma of Lung

In brief

This study is an observational study of blood and tissue biomarkers. Investigators plan to evaluate the accuracy of lung cancer biomarkers found in the blood in determining if a lung nodule is cancer or benign. Investigators also plan to examine another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer. Finally, investigators plan to determine if one of the blood-based biomarkers can be used to detect any late cancer recurrence.

Key facts

Study ID

NCT05665504

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

250

Starts

2023-01-11

Expected to finish

2028-02-01

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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