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

Launched by INVIVOSCRIBE, INC. · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new test called the IdentiClone Dx TRG Assay, which helps doctors better understand a type of blood disorder known as T-Cell Lymphoproliferative Disorder. The goal is to see how accurately this new test's results match those from an existing, trusted test. Researchers will use leftover DNA samples from patients who have been suspected of having this disorder to compare the results from both tests.

To be eligible for this study, participants must be at least 18 years old and have specific types of tissue samples that have been preserved in a special way. These samples should either show signs of T-cell Lymphoproliferative Disease or be from patients suspected of having it but diagnosed otherwise. The study is not yet recruiting participants, and those who join can expect their samples to be analyzed for research purposes to help improve testing methods for this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. De-identified, residual FFPE specimens with a minimum of 8 curls
• • 2. Subject Age ≥ 18
• 3. For suspected clonal positive specimens, FFPE specimens of subjects diagnosed (at the time the specimen was drawn) with T-cell Lymphoproliferative disease with at least one of the following:
• • 1. ICD10 Codes: C84, C85.8, C85.9, C86.1, C86.2, C86.3, C86.5, 86.6, C91.5, C91.6, C91.0, C91.z, C91.9, C94, C95, C96, or other T-cell lymphoma diagnosis
• • 2. b. T-cell lymphoproliferative disease diagnosis per collection site procedure (e.g., SNOMED)
• • 3. Mycosis fungoides or Sézary syndrome sample are acceptable
• • 4. For suspected clonal negative specimens, FFPE specimens of subjects suspected of T-cell lymphoproliferative disease but diagnosed negative for T-cell lymphoproliferative disease. Up to 20% of the negative specimens may be from normal tissue or tissue diagnosed with diseases other than T-cell lymphoproliferative disease
• Exclusion Criteria:
• • 1.FFPE specimens that were fixed using formalin substitute (ethanol, methanol, etc.)