Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy

NCT ID: NCT04014764

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-15
• Study Completion Date: 2022-03-31

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.

Conditions

Acute Myelogenous Leukemia; Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Myeloproliferative Neoplasm

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Single group

Documented hematologic malignancy in need of starting an active anti-cancer therapy.

This is a non-interventional study.

This is a non-interventional study

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Notable Labs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroomi Tada, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Notable Labs

Locations

CBCC Global Research

Bakersfield, California, United States

Pacific Central Coast Health Centers -- SLO Oncology and Hematology Health Center

San Luis Obispo, California, United States

Colorado West Healthcare System, dba Grand Valley Oncology

Grand Junction, Colorado, United States

Ocala Oncology Center

Ocala, Florida, United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States

Touro Infirmary

New Orleans, Louisiana, United States

Northern Light Cancer Care Center

Brewer, Maine, United States

New York Cancer and Blood Specialists

Port Jefferson Station, New York, United States

East Carolina University

Greenville, North Carolina, United States

The Lindner Center for Research and Education at The Christ Hospital -- The Cancer Center

Cincinnati, Ohio, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

University Hospital of Alexandroupolis

Alexandroupoli, , Greece

National Kapodistrian University of Athens

Athens, , Greece

Attikon University Hospital

Athens, , Greece

National Kapodistrian Hospital/Laikon General Hospital

Athens, , Greece

University Hospital of Ioánnina

Ioannina, , Greece

University Hospital Patras

Pátrai, , Greece

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital San Pedro de Alcántare

Cáceres, , Spain

Hospital Universitari I Politècnic La Fe

Valencia, , Spain

Countries

United States; Greece; Spain

Other Identifiers

N-01

Identifier Type: -

Identifier Source: org_study_id