Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay

Invivoscribe

Status: Completed

Conditions: B-Cell Lymphoproliferative Disorder

Treatments: Diagnostic Test: IdentiClone Dx IGH (IC IGH Dx) Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT06112301

IVS-108-001

Details and patient eligibility

About

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 and a predicate devise or assay on retrospective and residual de-identified DNA extracted from peripheral blood (PB) samples from individuals with suspected B-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq (LT Dx IGH-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC IGH Assay on the same sample type.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. DNA extracted from Peripheral Blood (PB) with EDTA as anticoagulant with minimum total DNA ≥ 2 µg with concentration at ≥ 50ng/µl

2. DNA extracted from PB specimens no more than 7 days

3. DNA stored at -15°C to -30°C up to 5 years

4. Donor Age: ≥ 18

5. For positive sample, DNA from PB of subjects diagnosed (at the time the specimen was drawn) with Lymphoproliferative disease, with:

   1. ICD 10 Codes: C8300, C8330, C8510 or other B-cell leukemia/lymphoma diagnosis
   2. B-cell Lymphoproliferative disease diagnosis per collection site procedure (i.e. SNOMED)

6. For negative sample, DNA from PB of subjects suspected of Lymphoproliferative disease

Exclusion criteria

1. PB specimens that have been frozen prior to extraction

Trial design

250 participants in 2 patient groups

B-Cell Positive Lymphoproliferative Disorders

Description:

DNA Samples for subjects with B-Cell Positive Lymphoproliferative Disorders

Treatment:

Diagnostic Test: IdentiClone Dx IGH (IC IGH Dx) Assay

B-Cell Negative Lymphoproliferative Disorders

Description:

DNA Samples for subjects suspected of B-Cell Positive Lymphoproliferative Disorders with negative B-Cell Clonality testing

Treatment:

Diagnostic Test: IdentiClone Dx IGH (IC IGH Dx) Assay