Clinical trial NCT04014764: Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy
Official title: An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myelogenous Leukemia
Multiple Myeloma
Myelodysplastic Syndromes
Lymphoma
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
Myeloproliferative Neoplasm
Lead sponsor: Notable Labs
Sponsor class: INDUSTRY
First posted: 2019-07-10
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical response to treatment
timeFrame: 3 years
Secondary outcomes:
measure: Type of clinical treatment responses
timeFrame: 3 years
measure: Types of somatic tumor mutations
timeFrame: 3 years
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: CBCC Global Research
state: California
city: San Luis Obispo
country: United States
facility: Pacific Central Coast Health Centers -- SLO Oncology and Hematology Health Center
state: California
city: Grand Junction
country: United States
facility: Colorado West Healthcare System, dba Grand Valley Oncology
state: Colorado
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center
state: Florida
city: New Orleans
country: United States
facility: Touro Infirmary
state: Louisiana
city: Brewer
country: United States
facility: Northern Light Cancer Care Center
state: Maine
city: Port Jefferson Station
country: United States
facility: New York Cancer and Blood Specialists
state: New York
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at The Christ Hospital -- The Cancer Center
state: Ohio
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Alexandroupolis
country: Greece
facility: University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: National Kapodistrian University of Athens
city: Athens
country: Greece
facility: Attikon University Hospital
city: Athens
country: Greece
facility: National Kapodistrian Hospital/Laikon General Hospital
city: Ioánnina
country: Greece
facility: University Hospital of Ioánnina
city: Patras
country: Greece
facility: University Hospital Patras
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántare
city: Valencia
country: Spain
facility: Hospital Universitari I Politècnic La Fe
Study officials:
affiliation: Notable Labs
name: Hiroomi Tada, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: