Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy ((ANSWer))

An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Myelodysplastic Syndromes; Multiple Myeloma; Acute Lymphoblastic Leukemia; Acute Myelogenous Leukemia; Chronic Myelogenous Leukemia; Myeloproliferative Neoplasm
• Intervention / Treatment: Other: This is a non-interventional study

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.

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• Greece
  • Alexandroupolis, Greece, 68100
    • University Hospital of Alexandroupolis
  • Athens, Greece, 12462
    • Attikon University Hospital
  • Athens, Greece, 11527
    • National Kapodistrian University of Athens
  • Athens, Greece
    • National Kapodistrian Hospital/Laikon General Hospital
  • Ioánnina, Greece, 45500
    • University Hospital of Ioannina
  • Patras, Greece, 26504
    • University Hospital Patras
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcántare
  • Valencia, Spain, 46026
    • Hospital Universitari I Politecnic La Fe
• United States
  • California
    • Bakersfield, California, United States, 93309
      • CBCC Global Research
    • San Luis Obispo, California, United States, 93401
      • Pacific Central Coast Health Centers -- SLO Oncology and Hematology Health Center
  • Colorado
    • Grand Junction, Colorado, United States, 81505
      • Colorado West Healthcare System, dba Grand Valley Oncology
  • Florida
    • Ocala, Florida, United States, 34474
      • Ocala Oncology Center
    • Orange City, Florida, United States, 32763
      • Mid Florida Hematology and Oncology Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Touro Infirmary
  • Maine
    • Brewer, Maine, United States, 04412
      • Northern Light Cancer Care Center
  • New York
    • Port Jefferson Station, New York, United States, 11776
      • New York Cancer and Blood Specialists
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Center for Research and Education at The Christ Hospital -- The Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approximately 1000 Subjects with diagnosed with a hematological malignancy will be enrolled to provide at least 1000 biospecimen samples.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single group; Documented hematologic malignancy in need of starting an active anti-cancer therapy. This is a non-interventional study.	Other: This is a non-interventional study; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	3 years

Collaborators and Investigators

• Sponsor: Notable Labs
• Investigators: Principal Investigator: Hiroomi Tada, MD, Ph.D., Notable Labs

Publications and helpful links

Helpful Links

• Site Feasibility Questionnaire, public study information

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2019
• Primary Completion (ACTUAL): March 31, 2022
• Study Completion (ACTUAL): March 31, 2022

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (ACTUAL): July 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Leukemia, Lymphoid; Myelodysplastic Syndromes; Multiple Myeloma; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myeloproliferative Disorders
• Other Study ID Numbers: N-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No