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NCT02741999 · ClinicalTrials.gov registry record
A Diagnostic Screening Trial Seeking AL Amyloidosis Very Early
A clinical trial, sponsored by Tufts Medical Center.
- Completed
- Registry status
- 20
- Enrollment target
NCT02741999: Completed study, sponsored by Tufts Medical Center.
NCT02741999 is a clinical trial that has completed, run by Tufts Medical Center. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02741999 has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
This protocol seeks to enroll smoldering multiple myeloma (SMM) and monoclonal gammopathy of undetermined significant (MGUS) patients with λ light chain (LC) involvement, a group of patients for whom standard of care is observation not treatment. Patients with SMM and MGUS have a precursor plasma cell disorder from which light chain amyloidosis (AL) can evolve. In this trial, enrolled subjects will have blood and if available bone marrow cells evaluated by molecular testing to determine their clonal λ LC variable region (VL) germline gene. Seventy percent of AL cases involve just 7 germline donors, 5 of which are λ germline donors. The hypothesis that will be tested with this protocol is that the presence of AL germline genes associated with AL in patients with a pre-existing diagnosis of λ SMM or λ MGUS indicates the presence of AL or risk of progression to AL.
Primary Outcome
After sequencing of their light chain (LC) variable region (VL) germline gene, subjects with light chain amyloidosis (AL) associated sequences will be followed for up to 5 years to monitor the potential progression of their disease to AL amyloidosis.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-04 |
| Est. Completion | 2020-04-05 |
What the finished NCT02741999 record still lists
NCT02741999 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02741999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02741999 about?
NCT02741999 is a clinical study titled "A Diagnostic Screening Trial Seeking AL Amyloidosis Very Early". This protocol seeks to enroll smoldering multiple myeloma (SMM) and monoclonal gammopathy of undetermined significant (MGUS) patients with λ light chain (LC) involvement, a group of patients for whom standard of care is observation not treatment. Patients with SMM and MGUS have a precursor plasma ce...
What is the current status of trial NCT02741999?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2016-04. Estimated completion is 2020-04-05.
Who is sponsoring clinical trial NCT02741999?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
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