Status:
COMPLETED
Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay
Lead Sponsor:
Invivoscribe, Inc.
Conditions:
B-Cell Lymphoproliferative Disorder
Eligibility:
All Genders
18+ years
Brief Summary
This protocol describes the pivotal accuracy study for the IdentiClone Dx IGH (IC IGH Dx) Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC IGH Dx Assay...
Eligibility Criteria
Inclusion
- DNA extracted from Peripheral Blood (PB) with EDTA as anticoagulant with minimum total DNA ≥ 2 µg with concentration at ≥ 50ng/µl
- DNA extracted from PB specimens no more than 7 days
- DNA stored at -15°C to -30°C up to 5 years
- Donor Age: ≥ 18
- For positive sample, DNA from PB of subjects diagnosed (at the time the specimen was drawn) with Lymphoproliferative disease, with:
- ICD 10 Codes: C8300, C8330, C8510 or other B-cell leukemia/lymphoma diagnosis
- B-cell Lymphoproliferative disease diagnosis per collection site procedure (i.e. SNOMED)
- For negative sample, DNA from PB of subjects suspected of Lymphoproliferative disease
Exclusion
- 1\. PB specimens that have been frozen prior to extraction
Key Trial Info
Start Date :
January 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 6 2024
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06112301
Start Date
January 2 2024
End Date
November 6 2024
Last Update
December 4 2024
Active Locations (3)
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1
Invivoscribe, Inc.
San Diego, California, United States, 92103
2
LabPMM GmbH
Hallbergmoos, Germany, 85399
3
LabPMM GK
Kawasaki-shi, Kanagawa, Japan, 210-0821