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)
1 other identifier
observational
119
3 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2019
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2019
CompletedFirst Posted
Study publicly available on registry
July 10, 2019
CompletedStudy Start
First participant enrolled
December 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedApril 5, 2022
April 1, 2022
2.3 years
July 3, 2019
April 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical response to treatment
Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank
3 years
Secondary Outcomes (2)
Type of clinical treatment responses
3 years
Types of somatic tumor mutations
3 years
Study Arms (1)
Single group
Documented hematologic malignancy in need of starting an active anti-cancer therapy. This is a non-interventional study.
Interventions
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.
Eligibility Criteria
Approximately 1000 Subjects with diagnosed with a hematological malignancy will be enrolled to provide at least 1000 biospecimen samples.
You may qualify if:
- 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;
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Notable Labslead
Study Sites (20)
CBCC Global Research
Bakersfield, California, 93309, United States
Pacific Central Coast Health Centers -- SLO Oncology and Hematology Health Center
San Luis Obispo, California, 93401, United States
Colorado West Healthcare System, dba Grand Valley Oncology
Grand Junction, Colorado, 81505, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763, United States
Touro Infirmary
New Orleans, Louisiana, 70115, United States
Northern Light Cancer Care Center
Brewer, Maine, 04412, United States
New York Cancer and Blood Specialists
Port Jefferson Station, New York, 11776, United States
East Carolina University
Greenville, North Carolina, 27834, United States
The Lindner Center for Research and Education at The Christ Hospital -- The Cancer Center
Cincinnati, Ohio, 45219, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
University Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
National Kapodistrian University of Athens
Athens, 11527, Greece
Attikon University Hospital
Athens, 12462, Greece
National Kapodistrian Hospital/Laikon General Hospital
Athens, Greece
University Hospital of Ioánnina
Ioannina, 45500, Greece
University Hospital Patras
Pátrai, 26504, Greece
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital San Pedro de Alcántare
Cáceres, 10003, Spain
Hospital Universitari I Politècnic La Fe
Valencia, 46026, Spain
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hiroomi Tada, MD, Ph.D.
Notable Labs
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2019
First Posted
July 10, 2019
Study Start
December 15, 2019
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
April 5, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share