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NCT06876571 · ClinicalTrials.gov registry record
Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay
A clinical trial, sponsored by Invivoscribe.
- Not yet
- Registry status
- 250
- Enrollment target
NCT06876571 is a clinical trial that has not yet begun recruiting, run by Invivoscribe. The registered enrollment target is 250 participants.
The verdict
NCT06876571 has not yet begun recruiting, sponsored by Invivoscribe.
- NOT YET RECRUITING
- Registry status
- 250 participants
- Enrollment target
Study Summary
This protocol describes the pivotal accuracy study for the IdentiClone Dx TRG Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC TRG Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from FFPE (Formalin Fixed Paraffin Embedded) samples from individuals with suspected T-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx TRG (FR1/FR2/FR3) Assays - MiSeq (LT Dx TRG-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC TRG Assay on the same sample type.
Interventions
- DIAGNOSTIC_TEST IdentiClone Dx TRG Assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2025-06-02 |
| Est. Completion | 2025-12-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06876571
The ClinicalTrials.gov registry entry for NCT06876571 describes a study currently listed as not yet recruiting, categorized as an unspecified phase. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Invivoscribe, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IdentiClone Dx TRG Assay is the first listed.
NCT06876571 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06876571 about?
NCT06876571 is a clinical study titled "Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay". This protocol describes the pivotal accuracy study for the IdentiClone Dx TRG Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC TRG Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from FFPE (Formalin F...
What is the current status of trial NCT06876571?
This trial is currently not yet recruiting. The enrollment target is 250 participants. The study started on 2025-06-02. Estimated completion is 2025-12-06.
What interventions are being tested in trial NCT06876571?
The interventions under investigation include: IdentiClone Dx TRG Assay (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06876571?
This trial is sponsored by Invivoscribe, which has 3 total clinical trials registered on ClinicalTrials.gov.
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