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

Sponsor

Notable Labs (Industry)

Overall Status

Completed

CT.gov ID

NCT04014764

Collaborator

(none)

119

Enrollment

Locations

27.5

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

119 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

An Observational Study to Collect and Assess Tissue Samples From Subjects With One of Three Neoplastic Conditions (ANSWer)

Actual Study Start Date :

Dec 15, 2019

Actual Primary Completion Date :

Mar 31, 2022

Actual Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Clinical response to treatment [3 years]
Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank

Secondary Outcome Measures

Type of clinical treatment responses [3 years]
Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses.
Types of somatic tumor mutations [3 years]
Determine genotype and/or phenotype relationships between ex vivo and clinical responses with somatic tumor mutations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CBCC Global Research	Bakersfield	California	United States	93309
2	Pacific Central Coast Health Centers -- SLO Oncology and Hematology Health Center	San Luis Obispo	California	United States	93401
3	Colorado West Healthcare System, dba Grand Valley Oncology	Grand Junction	Colorado	United States	81505
4	Ocala Oncology Center	Ocala	Florida	United States	34474
5	Mid Florida Hematology and Oncology Center	Orange City	Florida	United States	32763
6	Touro Infirmary	New Orleans	Louisiana	United States	70115
7	Northern Light Cancer Care Center	Brewer	Maine	United States	04412
8	New York Cancer and Blood Specialists	Port Jefferson Station	New York	United States	11776
9	East Carolina University	Greenville	North Carolina	United States	27834
10	The Lindner Center for Research and Education at The Christ Hospital -- The Cancer Center	Cincinnati	Ohio	United States	45219
11	Utah Cancer Specialists	Salt Lake City	Utah	United States	84106
12	University Hospital of Alexandroupolis	Alexandroupolis		Greece	68100
13	National Kapodistrian University of Athens	Athens		Greece	11527
14	Attikon University Hospital	Athens		Greece	12462
15	National Kapodistrian Hospital/Laikon General Hospital	Athens		Greece
16	University Hospital of Ioánnina	Ioánnina		Greece	45500
17	University Hospital Patras	Patras		Greece	26504
18	Hospital General Universitario de Alicante	Alicante		Spain	03010
19	Hospital San Pedro de Alcántare	Cáceres		Spain	10003
20	Hospital Universitari I Politècnic La Fe	Valencia		Spain	46026