Lung Cancer Clinical Trial
Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
This study is designed 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 use another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer so that they can be offered additional drug treatment that will improve their chances of long-term cure. Finally, investigators plan to use one of the blood-based biomarkers to detect any late cancer recurrence
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.
Participants must have adequate organ and bone marrow function as defined below:
a. absolute neutrophil count ≥1,000/mcL
b. platelets ≥70,000/mcL
c. total bilirubin ≤ institutional upper limit of normal (ULN)
d. AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
e. creatinine 3.0 ≤ institutional ULN
Agree to participate in the follow-up protocol.
Any 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.
Participants who have had chemotherapy or radiotherapy within 2 years of entering the study.
Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1), with the exception of alopecia.
Participants who are actively receiving any cancer treatment.
History of allergic reactions attributed to adjuvant chemotherapy agents used in study.
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.
Pregnant or lactating female.
Patient unable to provide informed consent.
Prisoner or incarcerated individual.
For surgical patients, a R1 or R2 resection.
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There is 1 Location for this study
Tampa Florida, 33612, United States More Info
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