Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04545333
Status:
TERMINATED
Last Update Posted:
2023-06-22
First Post:
2020-08-31
Brief Title:
The clonoSEQ Watch Registry
Sponsor:
Adaptive Biotechnologies
Organization:
Adaptive Biotechnologies
Study Overview
Official Title:
Real World Observational Study Using clonoSEQ Next Generation Sequencing in Hematologic Malignancies The Watch Registry
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sufficient data collected
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None