Clinical trial NCT05665504: Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
Official title: Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung; Node
Adenocarcinoma of Lung
Keywords: Biomarkers
Lung Cancer Biomarkers
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seen in the Moffitt Thoracic Surgery and Lung Diagnosis Clinics.

Brief 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: 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.

Primary outcomes:
measure: Disease Free Survival
timeFrame: Up to 5 years
measure: Overall Survival
timeFrame: Up to 5 Years
Secondary outcomes:
measure: Tumor Malignancy
timeFrame: At 6 Months
measure: Cancer Recurrence
timeFrame: At 6 Months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Lary A Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References: