CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice (N1)
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|ClinicalTrials.gov Identifier: NCT02900248|
Recruitment Status : Terminated (Registry was built to handle Medicare coverage decision on NGS, but CMS decided to not require data.)
First Posted : September 14, 2016
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment|
|Neoplasms Lung Neoplasms Colon Neoplasms Breast Neoplasms Pancreatic Neoplasms Prostate Neoplasms Kidney Neoplasms Liver Neoplasms Rectal Neoplasms Hematologic Neoplasms Multiple Myeloma Myelodysplastic Syndromes Ovarian Neoplasms Bladder Neoplasms Testicular Neoplasms Endometrial Neoplasms Brain Neoplasms Biliary Tract Neoplasms Head and Neck Neoplasms Uterine Cervical Neoplasms Skin Neoplasms Melanoma Gastric Neoplasms Anal Neoplasms Sarcoma||Other: Provider determined|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||23 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Patients Diagnosed With Advanced Malignancy or Myelodysplasia, Tested by Standardized Sequencing, and Treated by Physician-Determined Care Plan: A CureOne Observational Registry (N1)|
|Actual Study Start Date :||October 2, 2017|
|Actual Primary Completion Date :||March 29, 2019|
|Actual Study Completion Date :||March 29, 2019|
Provider Determined Treatment
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.
Other: Provider determined
Provider will treat patient as he/she feels best
- 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).
- Overall Survival [ Time Frame: 5 years ]Overall survival by biomarker
- Establish stable estimates of biomarker prevalence in patients with advanced malignancies in a large population. [ Time Frame: 5 years ]Establish stable estimates of biomarker prevalence in patients with advanced malignancies in a large population.
- To determine rate of enrollment into existing and future therapeutic clinical trials. [ Time Frame: 5 years ]To determine rate of enrollment into existing and future therapeutic clinical trials.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900248
|United States, Idaho|
|Teton Cancer Institute|
|Idaho Falls, Idaho, United States, 83404|
|Principal Investigator:||Razelle Kurzrock, M.D.||Moores Cancer Center, University of California at San Diego|
|Study Chair:||John Pfeifer, M.D., Ph.D.||Washington University School of Medicine|
|Study Director:||Dane J. Dickson, M.D.||CureOne/Knight Cancer Center, Oregon Health and Science University|