Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy ((ANSWer))
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ClinicalTrials.gov Identifier: NCT04014764 |
Recruitment Status :
Completed
First Posted : July 10, 2019
Last Update Posted : April 5, 2022
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Condition or disease | Intervention/treatment |
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Acute Myelogenous Leukemia Multiple Myeloma Myelodysplastic Syndromes Lymphoma Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Myeloproliferative Neoplasm | Other: This is a non-interventional study |
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 [Patient Registry] |
Actual Enrollment : | 119 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) |
Actual Study Start Date : | December 15, 2019 |
Actual Primary Completion Date : | March 31, 2022 |
Actual Study Completion Date : | March 31, 2022 |

Group/Cohort | Intervention/treatment |
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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. |
- Clinical response to treatment [ Time Frame: 3 years ]Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank
- Type of clinical treatment responses [ Time Frame: 3 years ]Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses.
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
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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

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 ClinicalTrials.gov identifier (NCT number): NCT04014764

Principal Investigator: | Hiroomi Tada, MD, Ph.D. | Notable Labs |
Responsible Party: | Notable Labs |
ClinicalTrials.gov Identifier: | NCT04014764 |
Other Study ID Numbers: |
N-01 |
First Posted: | July 10, 2019 Key Record Dates |
Last Update Posted: | April 5, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Leukemia 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 Neoplasms, Plasma Cell Hemostatic Disorders |
Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Leukemia, Lymphoid Lymphatic Diseases |