CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice

Terminated

• Conditions: Lung Neoplasms; Colon Neoplasms; Prostate Neoplasms; Endometrial Neoplasms; Hematologic Neoplasms; Biliary Tract Neoplasms; Melanoma; Neoplasms; Breast Neoplasms; Multiple Myeloma
• Interventions: Other: Provider determined

• Registration Number: NCT02900248
• Lead Sponsor: CureOne

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.

Study Timeline

• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-14
• Study Start: 2017-10-02
• Status Verified: 2018-08
• Primary Completion: 2019-03-29
• Study Completion: 2019-03-29
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Provider Determined Treatment	Provider determined	Participants with advanced solid or hematologic malignancy or myelodysplasia (MDS), will have their tumor or tissue tested by a standardized next generation sequencing (NGS) panel. They will be treated by physician determined treatment including FDA approved or compendia-listed biomarker directed therapy. All patients will be followed for time to progression by line of therapy, overall survival by line of therapy.

Primary Outcome Measures

Name	Time	Method
Best Overall Response	5 years	Best overall response by line of therapy and biomarker
Time to Treatment Progression	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 Outcome Measures

Name	Time	Method
Overall Survival	5 years	Overall survival by biomarker
To determine rate of enrollment into existing and future therapeutic clinical trials.	5 years	To determine rate of enrollment into existing and future therapeutic clinical trials.
Establish stable estimates of biomarker prevalence in patients with advanced malignancies in a large population.	5 years	Establish stable estimates of biomarker prevalence in patients with advanced malignancies in a large population.

Trial Locations

Locations (1)

Teton Cancer Institute; 🇺🇸 Idaho Falls, Idaho, United States