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

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


  • Org Study ID: N1OR
  • Secondary ID:
  • NCT ID: NCT02900248
  • NCT Alias:
  • Sponsor: CureOne - Other
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting October 2, 2017 N/A Observational [Patient Registry]

Primary Outcomes:

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

Condition:

  • 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

Eligibility

Criteria:
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).
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Razelle Kurzrock, M.D.

Role: Principal Investigator

Affiliation: Moores Cancer Center, University of California at San Diego

Overall Contact

Name: Judy Taylor

Phone: 202.800.0614

Email: Judy.Taylor@CureOne.org

Location

Facility Status Contact
Teton Cancer Institute
Idaho Falls, Idaho 83404
United States
Recruiting Lisa Anderson, RN
208-523-1100
lisaanderson5@tetoncancer.com