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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04014764
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : July 19, 2019
Information provided by (Responsible Party):
Notable Labs

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.

Condition or disease Intervention/treatment
Acute Myelogenous Leukemia Multiple Myeloma Myelodysplastic Syndromes Lymphoma Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Myeloproliferative Neoplasm 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

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.

Primary Outcome Measures :
  1. Clinical response to treatment [ Time Frame: 3 years ]
    Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank

Secondary Outcome Measures :
  1. Type of clinical treatment responses [ Time Frame: 3 years ]
    Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses.

  2. Types of somatic tumor mutations [ Time Frame: 3 years ]
    Determine genotype and/or phenotype relationships between ex vivo and clinical responses with somatic tumor mutations.

Biospecimen Retention:   Samples With DNA
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

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)
  • ≥7 days from last anti-cancer therapy;
  • Any number of prior therapies
  • Subject may be re-enrolled at relapse or disease progression

Exclusion Criteria:

  • Unwilling or unable to give consent
  • Active disease is in remission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04014764

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Contact: Donna M Stram 9783400869 DONNA@CHIMERACLINICAL.COM
Contact: Susanna Wen

Sponsors and Collaborators
Notable Labs
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Principal Investigator: Hiroomi Tada, MD, Ph.D. Notable Labs

Additional Information:
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Responsible Party: Notable Labs Identifier: NCT04014764     History of Changes
Other Study ID Numbers: N-01
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Leukemia, Lymphoid
Lymphatic Diseases