Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, multicenter observational study to collect clinically annotated biospecimens in order to assess the correlation between ex vivo data generated by the Notable assay platform and clinical outcome.
This is a prospective, multicenter, observational study with collection of de-identified biospecimens with matched clinical data from up to 1000 participants from clinical networks in the United States and Canada. Clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical record at baseline (at study entry and time of baseline biospecimen collection), and subsequent visits per patient consent, for up to 1 year.
The primary assessment is the establishment of a tumor registry with annotated clinical outcomes. Exploratory assessments include correlation of ex vivo functional testing results with clinical outcomes, as well as identification of potential biomarkers that correlate responses with genotype and/or phenotype.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group | Documented hematologic malignancy in need of starting an active anti-cancer therapy. This is a non-interventional study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This is a non-interventional study | Other | N/A. This is a non-interventional study. Following consent, the subject will have biospecimen samples taken during routine standard of care procedures, and provided to Sponsor for analysis. Optional research blood draws may occur at treating physician's discretion to obtain additional tissue samples. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response to treatment | Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Type of clinical treatment responses | Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses. | 3 years |
| Types of somatic tumor mutations | Determine genotype and/or phenotype relationships between ex vivo and clinical responses with somatic tumor mutations. |
Not provided
Inclusion Criteria:
Note: *Supportive care agents including erythropoiesis-stimulating agents (ESAs) such as EPO, Procrit, Aranesp, etc; granulocyte colony stimulating factor (G-CSF); hydroxyurea (Hydrea); and luspatercept (Reblozyl) are not considered anti-cancer therapy for this study
Intent to start anti-cancer therapy within 21 days of biospecimen collection
•≥7 days from last anti-cancer therapy;
Any number of prior therapies
Subject cohort is currently open
Exclusion Criteria:
Not provided
Not provided
Not provided
Approximately 1000 Subjects with diagnosed with a hematological malignancy will be enrolled to provide at least 1000 biospecimen samples.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hiroomi Tada, MD, Ph.D. | Notable Labs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CBCC Global Research | Bakersfield | California | 93309 | United States | ||
| Pacific Central Coast Health Centers -- SLO Oncology and Hematology Health Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will require tissue samples taken from consented subjects to be assayed using Notable's ex vivo, high-throughput flow cytometry based platform. The result of this assay will be compared to the subject's documented diagnosis as well as clinical outcome, where applicable. Additional biomarker testing, such as sequencing to determine somatic mutations using targeted panels, may also be conducted.
|
| 3 years |
| San Luis Obispo |
| California |
| 93401 |
| United States |
| Colorado West Healthcare System, dba Grand Valley Oncology | Grand Junction | Colorado | 81505 | United States |
| Ocala Oncology Center | Ocala | Florida | 34474 | United States |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763 | United States |
| Touro Infirmary | New Orleans | Louisiana | 70115 | United States |
| Northern Light Cancer Care Center | Brewer | Maine | 04412 | United States |
| New York Cancer and Blood Specialists | Port Jefferson Station | New York | 11776 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| The Lindner Center for Research and Education at The Christ Hospital -- The Cancer Center | Cincinnati | Ohio | 45219 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| University Hospital of Alexandroupolis | Alexandroupoli | 68100 | Greece |
| National Kapodistrian University of Athens | Athens | 11527 | Greece |
| Attikon University Hospital | Athens | 12462 | Greece |
| National Kapodistrian Hospital/Laikon General Hospital | Athens | Greece |
| University Hospital of Ioánnina | Ioannina | 45500 | Greece |
| University Hospital Patras | Pátrai | 26504 | Greece |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital San Pedro de Alcántare | Cáceres | 10003 | Spain |
| Hospital Universitari I Politècnic La Fe | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009101 | Multiple Myeloma |
| D009190 | Myelodysplastic Syndromes |
| D008223 | Lymphoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009196 | Myeloproliferative Disorders |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001855 | Bone Marrow Diseases |
| D008206 | Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided