Solid Tumor Neoplasms
Conditions
Keywords
Solid Tumor cancer
Brief summary
This is an observational study enrolling patients with Solid Tumor cancers to identify genomic expression differences between exceptional responders and non-responders to standard of care chemotherapy. Data analysis of the gene expression profile of the exceptional responders compared to non-responders will define genomic patterns that may help understand their response to chemotherapy.
Detailed description
This is an observational study of patients with solid tumor cancer to identify genomic expression differences obtained from their circulating tumor cells between exceptional responders and non-responders to standard of care chemotherapy. This study requires a 10 mL heparinized peripheral blood sample from each study participant at the time of enrollment to isolate, enrich and profile circulating tumor cells. Data analysis of the gene expression profile will define genomic patterns using Nearest Template Prediction for a predetermined panel of therapeutic agents based on standard of care. Chemotherapy selection is physician-choice. Information regarding disease progression will be gathered. Data analysis will be performed in study participants in the setting of ongoing disease progression.
Interventions
Physician's Choice Chemotherapy Treatment (non-guided)
Sponsors
Study design
Eligibility
Inclusion criteria
* Histological or cytological confirmation of solid tumor carcinoma. * Patient is treatment-naïve or currently receiving chemotherapy. * ECOG performance status (any).
Exclusion criteria
* HIV positive on antiretroviral therapy * Pregnant or lactating * Prior organ allograft * Any medical or psychiatric condition that may interfere with the ability to comply with protocol treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify exceptional responders with cancer to standard of care chemotherapy | 9 years | Identify responders and non-responders |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of genomic profiles from circulating cells with overall survival | 9 years | Genomic expression profiles correlated with progression free and overall survival |
Countries
United States