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

NCT02900248 | Terminated DMC

• 1 other identifier: N1OR
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Biomarkers; High-Throughput Nucleotide Sequencing; Neoplasms; Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (2)

• Best Overall Response

  Best overall response by line of therapy and biomarker

  5 years

• Time to Treatment Progression

  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 Outcomes (3)

• Overall Survival

  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.

  5 years

Study Arms (1)

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

Interventions

Provider determined OTHER

Provider will treat patient as he/she feels best

Provider Determined Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced malignancy or myelodysplasia

You may qualify if:

• Patient is ≥ 18 years old.
• 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.
• 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):
• 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.
• 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)
• Myelodysplasia with cytopenias at time of requiring treatment
• 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.
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at initial screening.
• Patient is willing and able to be treated by physician-determined care plan.
• Patient may participate in other clinical studies or registries while participating in this observational registry.
• Patient agrees with regular follow up (see Assessment Schedule below).

Sponsors & Collaborators

• CureOne: lead

Study Sites (1)

Teton Cancer Institute

Idaho Falls, Idaho, 83404, United States

Location

Related Publications (15)

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MeSH Terms

Conditions

Neoplasms; Lung Neoplasms; Colonic Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Prostatic Neoplasms; Kidney Neoplasms; Liver Neoplasms; Rectal Neoplasms; Hematologic Neoplasms; Multiple Myeloma; Myelodysplastic Syndromes; Ovarian Neoplasms; Urinary Bladder Neoplasms; Testicular Neoplasms; Endometrial Neoplasms; Brain Neoplasms; Biliary Tract Neoplasms; Head and Neck Neoplasms; Uterine Cervical Neoplasms; Skin Neoplasms; Melanoma; Stomach Neoplasms; Anus Neoplasms; Sarcoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases; Urologic Diseases; Liver Diseases; Rectal Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Gonadal Disorders; Urinary Bladder Diseases; Testicular Diseases; Uterine Neoplasms; Uterine Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Biliary Tract Diseases; Uterine Cervical Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Stomach Diseases; Anus Diseases; Neoplasms, Connective and Soft Tissue

Study Officials

• Razelle Kurzrock, M.D.

  Moores Cancer Center, University of California at San Diego

  PRINCIPAL INVESTIGATOR

• John Pfeifer, M.D., Ph.D.

  Washington University School of Medicine

  STUDY CHAIR

• Dane J. Dickson, M.D.

  CureOne/Knight Cancer Center, Oregon Health and Science University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: September 14, 2016
• Study Start: October 2, 2017
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: April 2, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)