CureOne Registry: Advanced Malignancy or Myelodysplasia, Tested by Standard Sequencing and Treated by Physician Choice (N1)

March 29, 2019 updated by: CureOne

Patients Diagnosed With Advanced Malignancy or Myelodysplasia, Tested by Standardized Sequencing, and Treated by Physician-Determined Care Plan: A CureOne Observational Registry (N1)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Teton Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced malignancy or myelodysplasia

Description

Inclusion:

  1. Patient is ≥ 18 years old.
  2. Patient is able to understand and agrees to comply with the requirements of the study and provides written informed consent indicating voluntary consent to participate in the registry. If the patient is unable to provide consent, but is able to comply with other study requirements, informed consent must be obtained by a durable power of attorney or healthcare proxy.

  3. Patient is diagnosed with any of the following malignancies or disorders AND with the corresponding American Joint Commission on Cancer (AJCC) 7th Edition Staging OR listed clinical scenario (i.e. a patient initially diagnosed with early stage lung cancer would not be a candidate, but if they later developed metastatic disease, they would be eligible and could be enrolled in this registry):

    1. Solid Malignancies Tumor Type (Initial Stage: Clinical Scenario) Lung and Bronchus (Stage IIIB or IV: Metastatic or Extensive) Colorectal (Stage IVB: Metastatic) Pancreas (Stage IV: Metastatic) Breast (Stage IV: Metastatic) Prostate (Stage IV: Castrate resistant) Hepatobiliary (Non-resectable: Metastatic) Tumor of Unknown Primary (Non-resectable: Initial Diagnosis) Bladder (Stage IV: Metastatic) Esophageal (Stage IV: Metastatic) Brain and CNS (All: Initial Diagnosis) Ovarian Cancer (Stage IV or Non-resectable: Recurrent) Kidney or Renal Pelvis (Stage IV: Metastatic) Stomach (Stage IV: Metastatic) Endometrial (Stage IV: Metastatic) Melanoma (Stage IV: Metastatic) Oral Cavity and Pharynx (Stage IVC: Metastatic) Less common Solid Malignancies* (Stage IV: Metastatic)

      *Defined as <1% annual death rate in the SEER database. This also includes histologies of common tumors that have been shown to have a more aggressive phenotype and require a different treatment approach than their more common counterparts.

    2. Hematologic Malignancies Tumor Type (Initial Stage: Clinical Scenario) Non-Hodgkins Lymphoma (N/A: Progressed or relapsed after initial treatment) Multiple Myeloma (Non-smoldering disease: Requiring Treatment) Acute Myelogenous Leukemia (N/A: Initial Diagnosis or Relapse) Chronic Lymphocytic Leukemia (N/A: Progressed or relapsed after initial therapy) Acute Lymphoblastic Leukemia (N/A: Initial Diagnosis or Relapse) Hodgkins Lymphoma (N/A: Progressed or relapsed after initial therapy) Chronic Myelogenous Leukemia (N/A: Progressed or relapsed after initial therapy) Less common Hematologic Malignancies (N/A: Requiring Treatment)
    3. Myelodysplasia with cytopenias at time of requiring treatment
  4. Unless otherwise specified, all participants will have NGS testing of an appropriate somatic tissue specimen (biopsy tissue or cell-free DNA) at a CureOne approved lab using the testing outlined in the protocol. The specimen used for testing must have been obtained within 6 months (180 days) preceding consent or on a specimen(s) obtained within 3 months (90 days) following consent to participate in this observational registry. Any non-registry biomarker testing must also be reported. Patient will be treated by physician-determined care plan.
  5. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at initial screening.
  6. Patient is willing and able to be treated by physician-determined care plan.
  7. Patient may participate in other clinical studies or registries while participating in this observational registry.
  8. Patient agrees with regular follow up (see Assessment Schedule below).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Overall Response
Time Frame: 5 years
Best overall response by line of therapy and biomarker
5 years
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).
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 5 years
Overall survival by biomarker
5 years
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.
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CureOne

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2017

Primary Completion (Actual)

March 29, 2019

Study Completion (Actual)

March 29, 2019

Study Registration Dates

First Submitted

June 18, 2015

First Submitted That Met QC Criteria

September 8, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N1OR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified genomic and general outcome information will be available for further research through curated independent research projects

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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