Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HEMMDS0035 | Other Identifier | OnCore | |
| IRB-45236 | Other Identifier | Stanford IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Notable Labs Inc. | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This non interventional study examines the feasibility of using patient specific therapeutic screening method, ex vivo to enhance current treatment recommendations in a clinically feasible time frame of 30 days.
This study utilizes the Notable Labs personalized testing service using an ex vivo assay, but does not involve actual treatment or treatment determinations. The results of these screenings will be made available to patients and their physicians for their use off study.
The primary objective of the study is:
• To determine the feasibility of selecting patient specific treatment regimens based on ex vivo within 30 days
The exploratory objectives of the study are:
• To identify biomarkers that explain ex vivo drug sensitivity results
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility testing | During the screening visit, blood and/or a bone marrow sample will be obtained for the patient's standard clinical evaluation. An aliquot of the blood and/or marrow sample will be obtained for ex vivo drug sensitivity assay |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with successful ex vivo results | Proportion of patients with successful ex vivo results within a 30 day period from the time marrow sample is sent to Notable Labs for ex vivo testing | 30 days |
| Proportion of patients with successful treatment decisions | Proportion of patients with successful treatment decisions made by the molecular oncology board within a 30 day period from the time marrow sample is sent to Notable Labs for ex vivo testing | 30 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study will be conducted at a single site, namely Stanford's MDS Center.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter L Greerberg | Stanford Universiy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford MDS Center | Stanford | California | 94304 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided