Patients Diagnosed With Advanced Malignancy or Myelodysplasia, Tested by Standardized Sequencing, and Treated by Physician-Determined Care Plan: A CureOne Observational Registry (N1)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- CureOne
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Best Overall Response
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
Registry participants with advanced malignancy or myelodysplasia will have a sample of their tumor or tissue analysed for genetic alterations using next generation sequencing (NGS) performed in a lab that has been certified to meet a high quality standard. Treatments and outcomes will be reported to the registry to allow further understanding of how genetic differences can lead to better diagnosis and treatments.
Detailed Description
Every malignancy or myelodysplasia is different on a molecular (genetic) level even in patients with the same diagnosis. These differences often give prognostic information, determine what types of treatments are available for a patient, as well as determine outcomes. In this registry, the method of identifying the genetic difference of the disease (using Next Generation Sequencing or NGS) is standardized, the treatments received by a patient, and the outcome of these treatments are entered into a database where all identifying information is removed. Payers (insurance companies) or others will generally pay for the testing, laboratories will report the genetic information, physicians and eventually patients will report treatments and outcomes. This information will then be reviewed frequently and analyzed to find better methods to improve the testing or treatments of disease. It is expected that dozens of other trials or registries will eventually be available for participants.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Best Overall Response
Time Frame: 5 years
Best overall response by line of therapy and biomarker
Time to Treatment Progression
Time Frame: 5 years
Physician-determined Time to Treatment Progression by line of therapy and method of determining progression (worsening of disease, new lesions, clinical decline, and/or other).
Secondary Outcomes
- Overall Survival(5 years)
- To determine rate of enrollment into existing and future therapeutic clinical trials.(5 years)
- Establish stable estimates of biomarker prevalence in patients with advanced malignancies in a large population.(5 years)