Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial study, sponsored by Invivoscribe.
NCT06876571 is a clinical trial that has not yet begun recruiting, run by Invivoscribe. The registered enrollment target is 250 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Agreement between the results of the Invivoscribe IdentiClone Dx TRG Assay and the LymphoTrack Dx TRG (FR1/FR2/FR3) Assays - MiSeq by assessing the positive and negative percent agreement between the two assays.
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 |
What is known before NCT06876571 opens enrollment
NCT06876571 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 TRG Assay is the first listed.
NCT06876571 does not publish any study locations in the registry export this page uses.
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.
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