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
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||October 2, 2017||N/A||Observational [Patient Registry]|
Primary Outcome 1 - Measure: Best Overall Response
Primary Outcome 1 - Time Frame: 5 years
Primary Outcome 2 - Measure: Time to Treatment Progression
Primary Outcome 2 - Time Frame: 5 years
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
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
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
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).
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Razelle Kurzrock, M.D.
Role: Principal Investigator
Affiliation: Moores Cancer Center, University of California at San Diego