Clinical trials

This is a feasibility trial to assess use of OncoTarget and OncoTreat testing in a basket design of patients with oligmetastasis across various solid tumor histology. Eligible oligometastatic patients that are receiving radiation therapy (n=20) will undergo mandatory tumor biopsy prior to precision medicine testing. Formalin fixed paraffin embedded tissue with \>50% tumor will be sent to the Laboratory of Personalized Genomic Medicine at Columbia University Medical Center for Darwin OncoTarget and OncoTreat testing. This will be supplementing routine clinical care with the goal of improving outcomes. The treating oncologist will decide to administer standard of care systemic therapy or proceed with treatment recommended by precision medicine testing. Feasibility outcomes include the ability to have the OncoTarget and OncoTreat test performed based on tumor type and pathology, ability to procure agents, change in medication use, and identification of unknown barriers. This study is assessing the use of precision medicine in a population has documented poor outcomes with implications aimed at improving these outcomes.

The purpose of the randomized control trial is to estimate the effect of an oncology clinical nurse specialist-led early intervention multidisciplinary approach to palliative and survivorship care within two previously identified and validated patient groups having metastatic solid tumor malignancy on patient-reported symptom burden, patient-reported overall quality of life (QOL), distress, and overall survival. The primary hypothesis is that the effect of an oncology clinical nurse specialist- led early intervention multidisciplinary palliative and survivorship care model will be significantly higher, as compared to the standard of care approach to palliative and survivorship care, on the primary endpoint of patient-reported symptom burden for patients with metastatic solid tumor malignancy within favorable and very favorable risk groups. Symptom burden includes pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, shortness of breath, and wellbeing.