Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06112301 · ClinicalTrials.gov registry record
Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay
A clinical trial, sponsored by Invivoscribe.
- Completed
- Registry status
- 250
- Enrollment target
NCT06112301 is a clinical trial that has completed, run by Invivoscribe. The registered enrollment target is 250 participants.
The verdict
NCT06112301 has completed, sponsored by Invivoscribe.
- COMPLETED
- Registry status
- 250 participants
- Enrollment target
Study 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.
Interventions
- DIAGNOSTIC_TEST IdentiClone Dx IGH (IC IGH Dx) Assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2024-01-02 |
| Est. Completion | 2024-11-06 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06112301
The ClinicalTrials.gov registry entry for NCT06112301 describes a study currently listed as completed, 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 IGH (IC IGH Dx) Assay is the first listed.
NCT06112301 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06112301 about?
NCT06112301 is a clinical study titled "Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay". 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 peri...
What is the current status of trial NCT06112301?
This trial is currently completed. The enrollment target is 250 participants. The study started on 2024-01-02. Estimated completion is 2024-11-06.
What interventions are being tested in trial NCT06112301?
The interventions under investigation include: IdentiClone Dx IGH (IC IGH Dx) Assay (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06112301?
This trial is sponsored by Invivoscribe, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.