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

Sponsor
Invivoscribe, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06112301
Collaborator
(none)
250
Enrollment
3
Locations
7
Anticipated Duration (Months)
83.3
Patients Per Site
12
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: IdentiClone Dx IGH (IC IGH Dx) Assay

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay
Anticipated Study Start Date :
Jan 2, 2024
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
B-Cell Positive Lymphoproliferative Disorders

DNA Samples for subjects with B-Cell Positive Lymphoproliferative Disorders

Diagnostic Test: IdentiClone Dx IGH (IC IGH Dx) Assay
The IdentiClone Dx IGH Assay is an in vitro diagnostic product intended for qualitative, capillary electrophoresis based-detection of clonality in immunoglobulin heavy chain gene rearrangements (IGH) in peripheral blood specimens as an adjunctive method for the diagnosis of B-cell lymphoproliferative disease
B-Cell Negative Lymphoproliferative Disorders

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

Diagnostic Test: IdentiClone Dx IGH (IC IGH Dx) Assay
The IdentiClone Dx IGH Assay is an in vitro diagnostic product intended for qualitative, capillary electrophoresis based-detection of clonality in immunoglobulin heavy chain gene rearrangements (IGH) in peripheral blood specimens as an adjunctive method for the diagnosis of B-cell lymphoproliferative disease

Outcome Measures

Primary Outcome Measures

  1. % Agreement [Through Study Completion at one year]

    Agreement between the results of the Invivoscribe IdentiClone Dx IGH Assay and the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq by assessing the positive and negative percent agreement between the two assays.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  6. ICD 10 Codes: C8300, C8330, C8510 or other B-cell leukemia/lymphoma diagnosis

  7. B-cell Lymphoproliferative disease diagnosis per collection site procedure (i.e. SNOMED)

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

Exclusion Criteria:
  1. PB specimens that have been frozen prior to extraction

Contacts and Locations

Locations

Site City State Country Postal Code
1 Invivoscribe, Inc. San Diego California United States 92103
2 LabPMM GmbH Hallbergmoos Germany 85399
3 LabPMM GK Kawasaki-shi Kanagawa Japan 210-0821

Sponsors and Collaborators

  • Invivoscribe, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Invivoscribe, Inc.
ClinicalTrials.gov Identifier:
NCT06112301
Other Study ID Numbers:
  • IVS-108-001
First Posted:
Nov 1, 2023
Last Update Posted:
Nov 1, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoproliferative Disorders

Study Results

No Results Posted as of Nov 1, 2023