Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay
NCT ID: NCT06876571
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
250 participants
OBSERVATIONAL
2025-06-02
2025-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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T-Cell Positive Lymphoproliferative Disorders
FFPE Samples for subjects with T-Cell Positive Lymphoproliferative Disorders
IdentiClone Dx TRG Assay
The IdentiClone Dx TRG Assay ("Assay") is an in vitro diagnostic product intended for qualitative capillary electrophoresis based-detection of clonality in T-cell receptor gamma chain (TRG) gene rearrangements in Formalin-Fixed Paraffin-Embedded (FFPE) specimens as an adjunctive method for the diagnosis of T-cell lymphoproliferative disease. This qualitative, non-automated Assay is for use on the ABI 3500xL Dx and ABI 3500xL Genetic Analyzers.
FFPE Samples for subjects Negative for T-Cell Lymphoproliferative Disorders
FFPE Samples for subjects Negative for T-Cell Lymphoproliferative Disorders
IdentiClone Dx TRG Assay
The IdentiClone Dx TRG Assay ("Assay") is an in vitro diagnostic product intended for qualitative capillary electrophoresis based-detection of clonality in T-cell receptor gamma chain (TRG) gene rearrangements in Formalin-Fixed Paraffin-Embedded (FFPE) specimens as an adjunctive method for the diagnosis of T-cell lymphoproliferative disease. This qualitative, non-automated Assay is for use on the ABI 3500xL Dx and ABI 3500xL Genetic Analyzers.
Interventions
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IdentiClone Dx TRG Assay
The IdentiClone Dx TRG Assay ("Assay") is an in vitro diagnostic product intended for qualitative capillary electrophoresis based-detection of clonality in T-cell receptor gamma chain (TRG) gene rearrangements in Formalin-Fixed Paraffin-Embedded (FFPE) specimens as an adjunctive method for the diagnosis of T-cell lymphoproliferative disease. This qualitative, non-automated Assay is for use on the ABI 3500xL Dx and ABI 3500xL Genetic Analyzers.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject Age ≥ 18
3. For suspected clonal positive specimens, FFPE specimens of subjects diagnosed (at the time the specimen was drawn) with T-cell Lymphoproliferative disease with at least one of the following:
1. ICD10 Codes: C84, C85.8, C85.9, C86.1, C86.2, C86.3, C86.5, 86.6, C91.5, C91.6, C91.0, C91.z, C91.9, C94, C95, C96, or other T-cell lymphoma diagnosis
2. b. T-cell lymphoproliferative disease diagnosis per collection site procedure (e.g., SNOMED)
3. Mycosis fungoides or Sézary syndrome sample are acceptable
4. For suspected clonal negative specimens, FFPE specimens of subjects suspected of T-cell lymphoproliferative disease but diagnosed negative for T-cell lymphoproliferative disease. Up to 20% of the negative specimens may be from normal tissue or tissue diagnosed with diseases other than T-cell lymphoproliferative disease
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Invivoscribe, Inc.
INDUSTRY
Responsible Party
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Locations
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Invivoscribe, Inc.
San Diego, California, United States
LabPMM GmbH
Hallbergmoos, , Germany
LabPMM GK
Kawasaki-shi, Kanagawa, Japan
Countries
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Facility Contacts
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Other Identifiers
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IVS-109-001
Identifier Type: -
Identifier Source: org_study_id
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