Notable Labs Protocol N-01: An Observational Study to Collect and Assess Tissue Samples from Subjects With Documented Hematologic Malignancy (ANSWer)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Creation of tumor registry

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Acute leukaemia

  Myelodysplastic syndrome

  Myeloproliferative neoplasm

  Chronic leukaemia

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  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.
• Outcomes:
  Establish a tumor registry with annotated clinical specimens. 1) assess whether or not correlation exists between ex vivo drug sensitivity data generated by the Notable assay platform and clinical outcome, and 2) determine whether there are genotype and/or phenotype correlations between ex vivo and clinical responses with somatic tumor mutations.
• Data analysis plan:
  There will be Minimal Risk to subjects who elect to donate specimens. Bone marrow aspirate samples are collected as part of routine medical care. Per FDA 21 CFR Part 812, blood and other remainder samples such as bone marrow may be collected as part of routine Standard Of Care (SOC). Blood samples collected via a non-SOC study-only blood draw are considered minimal risk as they will be collected from adult subjects and will not exceed 550 mL in an 8-week period and will not occur more than 2 times per week. Subjects will be properly informed of the risks of the procedure as part of the consent process. No known psychological risks will be involved as all subject identifiers will be encoded and inaccessible to any researchers except the Principal Investigator and personnel under their direct supervision.