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Spots Global Cancer Trial Database for The clonoSEQ® Watch Registry

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Trial Identification

Brief Title: The clonoSEQ® Watch Registry

Official Title: Real World Observational Study Using clonoSEQ® Next Generation Sequencing in Hematologic Malignancies: The 'Watch' Registry

Study ID: NCT04545333

Interventions

clonoSEQ Assay

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Stanford Hospital, Stanford, California, United States

Georgetown University, Washington, 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, Saint 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

Bon Secours St Francis, Greenville, South Carolina, United States

University of Washington, Seattle Cancer Care Alliance, Seattle, Washington, United States

Swedish Cancer Institute, Seattle, Washington, United States

Northwest Medical Specialties, Tacoma, Washington, United States

Contact Details

Name: Heidi Simmons, PhD

Affiliation: Adaptive Biotechnologies

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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