MedDataX Logo

Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay

NCT ID: NCT06112301

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-02

Study Completion Date

2024-11-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

B-Cell Lymphoproliferative Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

B-Cell Positive Lymphoproliferative Disorders

DNA Samples for subjects with B-Cell Positive Lymphoproliferative Disorders

IdentiClone Dx IGH (IC IGH Dx) Assay

Intervention Type DIAGNOSTIC_TEST

The IdentiClone Dx IGH Assay is an in vitro diagnostic product intended for qualitative, capillary electrophoresis based-detection of clonality in immunoglobulin heavy chain gene rearrangements (IGH) in peripheral blood specimens as an adjunctive method for the diagnosis of B-cell lymphoproliferative disease

B-Cell Negative Lymphoproliferative Disorders

DNA Samples for subjects suspected of B-Cell Positive Lymphoproliferative Disorders with negative B-Cell Clonality testing

IdentiClone Dx IGH (IC IGH Dx) Assay

Intervention Type DIAGNOSTIC_TEST

The IdentiClone Dx IGH Assay is an in vitro diagnostic product intended for qualitative, capillary electrophoresis based-detection of clonality in immunoglobulin heavy chain gene rearrangements (IGH) in peripheral blood specimens as an adjunctive method for the diagnosis of B-cell lymphoproliferative disease

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IdentiClone Dx IGH (IC IGH Dx) Assay

The IdentiClone Dx IGH Assay is an in vitro diagnostic product intended for qualitative, capillary electrophoresis based-detection of clonality in immunoglobulin heavy chain gene rearrangements (IGH) in peripheral blood specimens as an adjunctive method for the diagnosis of B-cell lymphoproliferative disease

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. DNA extracted from Peripheral Blood (PB) with EDTA as anticoagulant with minimum total DNA ≥ 2 µg with concentration at ≥ 50ng/µl
2. DNA extracted from PB specimens no more than 7 days
3. DNA stored at -15°C to -30°C up to 5 years
4. Donor Age: ≥ 18
5. For positive sample, DNA from PB of subjects diagnosed (at the time the specimen was drawn) with Lymphoproliferative disease, with:

1. ICD 10 Codes: C8300, C8330, C8510 or other B-cell leukemia/lymphoma diagnosis
2. B-cell Lymphoproliferative disease diagnosis per collection site procedure (i.e. SNOMED)
6. For negative sample, DNA from PB of subjects suspected of Lymphoproliferative disease

Exclusion Criteria

1\. PB specimens that have been frozen prior to extraction
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Invivoscribe, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Invivoscribe, Inc.

San Diego, California, United States

Site Status

LabPMM GmbH

Hallbergmoos, , Germany

Site Status

LabPMM GK

Kawasaki-shi, Kanagawa, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Germany Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IVS-108-001

Identifier Type: -

Identifier Source: org_study_id