Circulating Tumor DNA in Predicting Outcomes in Patients With Stage IV Head and Neck Cancer or Stage III-IV Non-small Cell Lung Cancer

Arms (1)

1. label

   Predictive value of circulating DNA

   description

   Patients undergo blood sample collection within 1 month before surgery, radiation therapy, or chemotherapy; within 1 week after surgical resection (for patients having upfront surgery); within 1 month before beginning of post-operative radiation therapy (for patients having upfront surgery); during the second week of radiation therapy, during the last week of radiation therapy; and at 1 and 3 months after radiation therapy and then every 3 months for up to 18 months. Patients also undergo saliva sample collection within 1 month before surgery, radiation therapy, chemoradiation therapy, or system chemotherapy and tissue collection at the time of surgery (if upfront surgery is indicated). Blood, saliva, and tissue samples are analyzed for tumor mutations via next generation sequencing.

   interventionNames

   1. Other: Cytology specimen
   2. Other: Laboratory biomarker analysis

Primary outcomes (1)

1. measure

   Predictive value of circulating tumor DNA for disease-free survival (DFS)/progression-free survival (PFS)

   timeFrame

   Up to 2 years

   description

   To evaluate the predictive value of circulating tumor DNA for DFS/PFS, Cox proportional model will be utilized. Circulating tumor DNA will be treated as either continuous or categorical variables in the regression models. The optimal cut-off value to dichotomize the patients by circulating tumor DNA will be determined by time-dependent receiver operating characteristic curve.