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



Status:Terminated
Conditions:Breast Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Colorectal Cancer, Skin Cancer, Ovarian Cancer, Cervical Cancer, Cervical Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Blood Cancer, Blood Cancer, Women's Studies, Hematology
Therapuetic Areas:Hematology, Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:October 2, 2017
End Date:March 29, 2019

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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.

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.

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).
We found this trial at
1
site
1957 East 17th Street
Idaho Falls, Idaho 83404
Principal Investigator: Jeffrey Hancock, MD
Phone: 208-523-1100
?
mi
from
Idaho Falls, ID
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