Acute Myelogenous Leukemia(ANSWer)NCT04014764
Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy
An observational study of Acute Myelogenous Leukemia and Multiple Myeloma, run by Notable Labs at 20 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, Multiple Myeloma, Myelodysplastic Syndromes
- What is being tested?
- This is a non-interventional study
- How many people
- 119 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 15 Dec 2019to 31 Mar 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 1000 Subjects with diagnosed with a hematological malignancy will be enrolled to provide at least 1000 biospecimen samples.
Who may be able to join
- 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)
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
United States11 sites
CBCC Global Research
Bakersfield, California, 93309
Northern Light Cancer Care Center
Brewer, Maine, 04412
The Lindner Center for Research and Education at The Christ Hospital -- The Cancer Center
Cincinnati, Ohio, 45219
Colorado West Healthcare System, dba Grand Valley Oncology
Grand Junction, Colorado, 81505
East Carolina University
Greenville, North Carolina, 27834
Touro Infirmary
New Orleans, Louisiana, 70115
Ocala Oncology Center
Ocala, Florida, 34474
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
New York Cancer and Blood Specialists
Port Jefferson Station, New York, 11776
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Pacific Central Coast Health Centers -- SLO Oncology and Hematology Health Center
San Luis Obispo, California, 93401
Greece6 sites
University Hospital of Alexandroupolis
Alexandroupoli, 68100
National Kapodistrian University of Athens
Athens, 11527
Attikon University Hospital
Athens, 12462
National Kapodistrian Hospital/Laikon General Hospital
Athens
University Hospital of Ioánnina
Ioannina, 45500
University Hospital Patras
Pátrai, 26504
Spain3 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital San Pedro de Alcántare
Cáceres, 10003
Hospital Universitari I Politècnic La Fe
Valencia, 46026
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Myelogenous Leukemia, Multiple Myeloma, Myelodysplastic Syndromes, Lymphoma, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
- Being tested
- This is a non-interventional study
- Medical subject headings
- Leukemia, Myeloid, Acute, Multiple Myeloma, Myelodysplastic Syndromes, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a non-interventional studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Documented hematologic malignancy in need of starting an active anti-cancer therapy.
This is a non-interventional study. Receives: Other: This is a non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response to treatment
Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank
Measured: 3 years
Secondary outcomes (2)
Type of clinical treatment responses
Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses.
Measured: 3 years
Types of somatic tumor mutations
Determine genotype and/or phenotype relationships between ex vivo and clinical responses with somatic tumor mutations.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start15 Dec 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Notable Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hiroomi Tada, MD, Ph.D., Principal investigator, Notable Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014764
- Sponsor's protocol ID
- N-01
- Acronym
- (ANSWer)
- Status last verified
- Apr 2022
- First submitted
- 3 Jul 2019
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)
- ClinicalTrials.gov ID
- NCT04014764
- Acronym / sponsor ID
- (ANSWer) / N-01
- Conditions
- Acute Myelogenous Leukemia, Multiple Myeloma, Myelodysplastic Syndromes, Lymphoma, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Notable LabsIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Other: This is a non-interventional studyDocumented hematologic malignancy in need of starting an active anti-cancer therapy. This is a non-interventional study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 1000 Subjects with diagnosed with a hematological malignancy will be enrolled to provide at least 1000 biospecimen samples.
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a non-interventional studyN/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. | Other | Single group |
Primary outcome
Clinical response to treatment
Time frame: 3 years
Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank
2 secondary outcomes
Type of clinical treatment responses
Time frame: 3 years
Types of somatic tumor mutations
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Site Feasibility Questionnaire, public study informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroomi Tada, MD, Ph.D. principal investigator
Notable Labs
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myelogenous Leukemia and Multiple Myeloma, run by Notable Labs at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Greece, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response to treatment (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.