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Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Allo-HSCT Recipients

NCT02156479 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 175

Last updated 2018-08-08

No results posted yet for this study

Summary

This study in a cohort of allo-HSCT recipients aims to validate the suitability of an improved T-Track® CMV assay to assess the functionality of CMV protein-reactive effector cells and its suitability to determine cut-off values mediating protection from recurrent CMV reactivations in allo-HSCT recipients.

Lophius T-Track® CMV represents a highly standardized and sensitive diagnostic tool to assess the functionality of a network of clinically relevant CMV-reactive effector cells. It is based on the stimulation of peripheral blood mononuclear cells (PBMC) with activated immunodominant CMV proteins, pp65 and IE-1, and the subsequent quantification of CMV-specific CMI (spot forming colonies) using a highly sensitive IFN-γ ELISpot.

Conditions

  • Cytomegalovirus Infection
  • GVHD

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Lophius Biosciences GmbH

    lead INDUSTRY

Principal Investigators

  • Daniel Wolff, Prof. Dr. med. · Klinik für Innere Medizin III, Hämatologie und Onkologie Regensburg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02156479 on ClinicalTrials.gov