Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndromes, Myeloproliferative Neoplasm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Notable Labs
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent; * Age ≥ 18 years, male or female, of any race; * Documented hematologic malignancy (any of the below) in need of starting an active anti-cancer therapy: * Acute myelogenous leukemia (AML) * Multiple myeloma (MM) * Myelodysplastic syndrome (MDS) * Lymphoma * Acute lymphocytic leukemia (ALL) * Chronic lymphocytic leukemia (CLL) * Chronic myelogenous leukemia (CML) * Neoplasm (MPN) * Other (upon review and approval by medical monitor) 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
* Unwilling or unable to give consent * Subject's disease is in remission * Subject cohort is not open at time of consent * Subject is restarting an ongoing treatment regimen after a dose interruption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response to treatment | 3 years | Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of clinical treatment responses | 3 years | Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses. |
| Types of somatic tumor mutations | 3 years | Determine genotype and/or phenotype relationships between ex vivo and clinical responses with somatic tumor mutations. |
Countries
Greece, Spain, United States
Outcome results
None listed