Precision Medicine for Patients With Identified Actionable Mutations

Status Terminated

Clinical Trial Summary

The goal of the current pragmatic trial is to evaluate the impact of a simple method of selecting a treatment approach for identified mutations on participants' progression free survival (PFS). The study also intends to collect information on barriers that investigators encounter when prescribing treatment options using the Next Generation Sequencing (NGS) reports. Additionally, patients' quality of life will be measured before, after, and during treatment. Patients will be followed until death for monitoring survival study endpoints.

Clinical Trial Description

Primary Objective: • To estimate the progression-free ratio, as defined by the progression-free survival time on study treatment divided by the progression-free survival time on the last treatment received by patient, for an identified actionable mutation, who will be treated with an off-label treatment off label therapy based on a simplified selection methodology using the Next Generation Sequencing results. Secondary Objectives: - To estimate patient response rate on off-label treatments for actionable mutations based on Next Generation Sequencing results. - To estimate overall survival (OS) for patients treated with off-label treatments for actionable mutations based on Next Generation Sequencing results. - To describe the safety of using off-label or other experimental treatments for patients with actionable mutations based on Next Generation Sequencing results. Exploratory Objectives: - To describe health related quality of life in patients undergoing off-label treatment targeting genetic mutations, as measured by the PROMIS-29 Overall Health-Related Quality of Life, Including 4-Item Anxiety Subscale. - Using the Satisfaction with Medical Decision Scale, to describe patient satisfaction with decision to pursue off-label treatment. - To identify types of actionable mutations with available targeted treatment occurring in cancer patients. - To characterize the historical treatment regimens for these patients relative to the targetable mutation. - To describe patient clinical and demographic characteristics of those with actionable mutations based on Next Generation Sequencing results. - To identify barriers to treatment based on Next Generation Sequencing results. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04111107
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Terminated
Phase	Phase 2
Start date	April 22, 2020
Completion date	February 9, 2023

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