NCT05665504Recruiting
Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
H. Lee Moffitt Cancer Center and Research Institute
Start Date
1/11/2023
Completion Date
2/1/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DIAGNOSTIC_TEST
DetermaRX
Conditions
Lung; NodeAdenocarcinoma of Lung
Locations
Moffitt Cancer Center
Tampa, Florida 33612
United States