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: Completed study, sponsored by Invivoscribe.
NCT06112301 is a clinical trial that has completed, run by Invivoscribe. The registered enrollment target is 250 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT06112301 record still lists
NCT06112301 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which IdentiClone Dx IGH (IC IGH Dx) Assay is the first listed.
NCT06112301 does not publish any study locations in the registry export this page uses.
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00483249 · 250 participants · NA
Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm
- NCT00777712 · 250 participants
Mechanisms Underlying Impaired Diabetic Wound Healing
- NCT01451502 · 250 participants · NA
Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
- NCT01771718 · 250 participants
Pilot Study on In-vivo Non-invasive Skin Imaging Using Multiphoton Microscopy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI