Genetic Exploration of the Molecular Basis of Malignancy in Adults — GEMMA  

Neoplasms Clinical Trial

Official title: Genetic Exploration of the Molecular Basis of Malignancy in Adults

Status Completed

Clinical Trial Summary

Genetic Exploration of the Molecular Basis of Malignancy in Adults.

Clinical Trial Description

This protocol is not designed as a treatment protocol. Patients enrolled on this study will be treated according to the treating physician's plan of care, independent of enrollment into the study. Once enrolled, the physician may proceed with the appropriate plan of care during the period of specimen analysis if indicated. Upon return of the results, therapy may or may not be altered based upon the patient's pathology, pertinent medical and treatment history, imaging studies, available clinical trials, and on the CLIA validated clinical molecular profiling results. Regardless of the results, the patient will be offered a treatment selected on an empirical basis by the treating physician at the individual site. All patients enrolled in the study will be followed for clinical outcome. Clinical molecular profiling results will expire 14 weeks following the date the Foundation One report is received. No investigational agents will be administered as part of this study. However, patients may be referred to open clinical trials based on the results of profiling. Patients referred for clinical trial may receive investigational agents under a separate clinical trial in accordance with the written protocol for which they are subsequently enrolled. All anti-neoplastic drugs used while participating in this study, whether used on-label or off-label, will be administered to the patient by the route of administration published in the FDA approved package insert. In addition, the dosing of the agent (including dose modifications) will be calculated based upon what is published in the FDA approved package insert. ;

Related Conditions & MeSH terms

• Neoplasms

• NCT number: NCT02416518
• Study type: Observational
• Source: Sanford Health
• Status: Completed
• Start date: May 2014
• Completion date: December 2018