Status:
NOT_YET_RECRUITING
Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay
Lead Sponsor:
Invivoscribe, Inc.
Conditions:
T-Cell Lymphoproliferative Disorder
Eligibility:
All Genders
18+ years
Brief 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 predi...
Eligibility Criteria
Inclusion
- De-identified, residual FFPE specimens with a minimum of 8 curls
- Subject Age ≥ 18
- 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:
- 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
- b. T-cell lymphoproliferative disease diagnosis per collection site procedure (e.g., SNOMED)
- Mycosis fungoides or Sézary syndrome sample are acceptable
- 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
- FFPE specimens that were fixed using formalin substitute (ethanol, methanol, etc.)
Key Trial Info
Start Date :
June 2 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 6 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06876571
Start Date
June 2 2025
End Date
December 6 2025
Last Update
March 14 2025
Active Locations (3)
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1
Invivoscribe, Inc.
San Diego, California, United States, 92103
2
LabPMM GmbH
Hallbergmoos, Germany, 85399
3
LabPMM GK
Kawasaki-shi, Kanagawa, Japan, 210-0821