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Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry
This is a prospective, multicenter, observational study of adult patients with a diagnosis of acute lymphoblastic leukemia (ALL), multiple myeloma (MM), chronic lymphocytic leukemia (CLL), or non-Hodgkin lymphoma (NHL). This study will enroll up to 528 patients in up to 50 sites in the United States and collect data with regard to use of the clonoSEQ MRD assay in the management of lymphoid malignancies.
Data show that detection of MRD may be important to guide treatment decisions in ALL, MM, CLL, and NHL. However, there remains a lack of real-world evidence for making therapeutic decisions based upon MRD status. This study is designed to understand when in a patient's treatment continuum the assay is used and how clonoSEQ MRD data impact the treatment decisions made by investigators. All patients enrolled in the study will be followed for at least 2 yrs. Demographic data and disease status will be captured at study enrollment. Patients must be \>/= 18 yrs of age and able to sign informed consent. A given patient is eligible to enroll in the study if the treating physician has made the decision to use the clonoSEQ assay as part of that patient's routine cancer care. Reasons for placing a clonoSEQ order and subsequent decisions made as a result of MRD data will be tracked. Patient treatment will also be tracked over the course of the study in order to understand how clonoSEQ use is incorporated into current treatment regimens. Participating centers will include sites that actively use clonoSEQ to manage their patients with lymphoid malignancies.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Stanford Hospital
Stanford, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Edward H. Kaplan MD & Associates
Skokie, Illinois, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
American Oncology Partners of Maryland
Bethesda, Maryland, United States
Washington University
St Louis, Missouri, United States
Novant Health
Charlotte, North Carolina, United States
Oregon Health & Science University, Knight Cancer Institute
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Start Date
October 13, 2020
Primary Completion Date
October 1, 2023
Completion Date
October 1, 2023
Last Updated
August 1, 2024
465
ACTUAL participants
clonoSEQ Assay
DIAGNOSTIC_TEST
Lead Sponsor
Adaptive Biotechnologies
NCT06152575
NCT06179888
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04973605