Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Disease Free Survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
High-Risk for Recurrence That Accept Adjuvant Chemotherapy
Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participants also have a special mutation on the tumor (EGFR), investigators will recommend that the participant also receive the oral anti-EGFR pill (TagrissoTM) daily for 3 years after completing the chemotherapy. The administration of standard postoperative chemotherapy is not considered part of the study. Only the results of the DetermaRx test is a part of this study.
干预措施: DetermaRX (Diagnostic Test)
High-Risk for Recurrence That Decline Adjuvant Chemotherapy
Participants whose gene assay show that they are at a higher risk of recurrence will be offered to receive postoperative chemotherapy. If participant declines, investigators will followup with participants periodically every 6-12 months over 5 years.
干预措施: DetermaRX (Diagnostic Test)
Low-Risk for Recurrence
Participants whose gene assay show that they are at a lower risk of recurrence will not be offered additional treatment after resection. Investigators will followup with participants periodically every 6-12 months over 5 years.
干预措施: DetermaRX (Diagnostic Test)
结局指标
主要结局
Disease Free Survival
时间窗: Up to 5 years
Disease-free survival (DFS) is defined as the time from surgical resection and adjuvant chemotherapy to recurrence of tumor or death
Overall Survival
时间窗: Up to 5 Years
Overall survival (OS) is defined as the time (days) from the date of surgical resection and adjuvant chemotherapy to the date of death, due to any reason.
次要结局
- Cancer Recurrence(At 6 Months)
- Tumor Malignancy(At 6 Months)