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NCT06112301
Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay
trial testing IdentiClone Dx IGH (IC IGH Dx) Assay in B-Cell Lymphoproliferative Disorder in 250 participants. Completed in 6 November 2024.
6 November 2024
Quick facts
| Lead sponsor | Invivoscribe, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 250 |
| Start date | 2 January 2024 |
| Primary completion | 6 November 2024 |
| Estimated completion | 6 November 2024 |
| Sites | 3 locations across Japan, United States, Germany |
Drugs / interventions tested
- IdentiClone Dx IGH (IC IGH Dx) Assay
Conditions studied
- B-Cell Lymphoproliferative Disorder — all drugs for B-Cell Lymphoproliferative Disorder →
Sponsor
Invivoscribe, Inc.
Who can join
18 and older, any sex, with B-Cell Lymphoproliferative Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06112301
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for B-Cell Lymphoproliferative Disorder
Currently open trials in the same condition.
- NCT06986174 — A Phase 2 Study to Evaluate the Safety and Efficacy of Pacritinib in Relapsed or Refractory Waldenström Macroglobulinemi · Phase 2 · recruiting
- NCT06510491 — Epcoritamab in Previously Treated WM · Phase 2 · recruiting
Other Invivoscribe, Inc. trials
Trials by the same sponsor.
- NCT06876571 — Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay · not yet recruiting
- NCT06222164 — The Use of Residual De-identified Specimens and/or Samples From Patients for Clinical Research · recruiting
- NCT04391400 — The Use of Peripheral Blood Specimens From Patients Suspected of Having SARS-CoV-2 Infections in Research Studies Intend · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06112301 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Invivoscribe, Inc.
- Last refreshed: 4 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06112301.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing