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NCT02555969 · ClinicalTrials.gov registry record
Minimal Residual Disease as a Possible Predictive Factor for Relapse in Patients With AL Amyloidosis
A clinical trial of Amyloidosis and Primary Amyloidosis, sponsored by Tufts Medical Center.
- Completed
- Registry status
- 56
- Enrollment target
- 1
- Study location
NCT02555969 is a study of Amyloidosis and Primary Amyloidosis that has completed, run by Tufts Medical Center. The registered enrollment target is 56 participants, below the 1,127-participant average among 28 other Amyloidosis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02555969, a study of Amyloidosis and Primary Amyloidosis, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
This protocol will assess patients with AL amyloidosis who achieve a complete response (CR) or very good partial response (VGPR) to therapy for minimal residual disease (MRD). Three approaches to MRD testing will be used since there is no established method. The investigators will clone and sequence each patient's light chain (LC) gene and design patient-specific primers to evaluate genomic DNA from future marrow specimens. Whole genome sequencing (WGS) will be used to test baseline and follow-up marrow cell DNA, seeking copy number variations in chromosomes 1 and 2 or 22, and structural variations in chromosomes 11 and 14, consistent with the known genetic abnormalities in AL and with clonal LC gene use. Plasma protein analysis by mass spectrometry will also be used to look for fragmentary protein sequences associated with the culprit LC gene of each subject. The feasibility and predictive value of these three approaches in patients achieving CR or VGPR will be evaluated. This protocol will help provide insight into the ways that the disease changes and progresses. MRD testing is likely an important next step in AL management.
Conditions Studied
Study Locations (1)
Massachusetts
- Tufts Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2015-08 |
| Est. Completion | 2020-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02555969
The ClinicalTrials.gov registry entry for NCT02555969 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,127-participant average among 28 other Amyloidosis trials with a reported enrollment target (95% lower). The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Amyloidosis appearing as the primary indexed condition, and to 0 interventions.
NCT02555969 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02555969 about?
NCT02555969 is a clinical study titled "Minimal Residual Disease as a Possible Predictive Factor for Relapse in Patients With AL Amyloidosis". This protocol will assess patients with AL amyloidosis who achieve a complete response (CR) or very good partial response (VGPR) to therapy for minimal residual disease (MRD). Three approaches to MRD testing will be used since there is no established method. The investigators will clone and sequence...
What is the current status of trial NCT02555969?
This trial is currently completed. The enrollment target is 56 participants. The study started on 2015-08. Estimated completion is 2020-08.
What conditions does trial NCT02555969 study?
This clinical trial studies the following conditions: Amyloidosis, Primary Amyloidosis.
Who is sponsoring clinical trial NCT02555969?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02555969 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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