B cell signalling differences in acute cellular rejection after lung transplantation (HAMLET)

B cell signalling differences in acute cellular rejection after lung transplantation (HAMLET) - Hamlet

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49616

Enrollment

Registered

2020-11-09

Start date

2021-01-06

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

afstoting long transplantaat host-versus-graft transplant rejection

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Patients (18-70 years) who underwent uni- or bilateral lung transplantation. AND 2. Written informed consent. AND 3. One or more episodes of acute cellular rejection within the first two years after lung transplantation OR 4. No episode of acute cellular rejection within the first two years after lung transplantation.

Exclusion criteria

Exclusion criteria: 1. Non-compliance to treatment 2. Active or treated malignancy (solid or hematological malignancies). 3. Who underwent a lung retransplantation. 4. Repetitive episodes of infection in advance of an episode of acute cellular rejection

Design outcomes

Primary

Measure	Time frame
- BTK protein expression in peripheral B cells. (flow cytometry). - BCR signalling, measured by increased phosphorylation of pSYK in in vitro stimulated B cells compared to unstimulated B cells. (culture and phosphoflow)	—

Secondary

Measure	Time frame
- To assess the T cell phenotype and activation - To assess the NK cell phenotype and activation - To measure the cytokine production by T cells - To determine Nuclear Factor kappa-B (NFkB) signaling in primary T cell subsets by means of flow cytometry. - Correlation of the findings in previously obtained peripheral lung biopsies; in order to clinico-pathologically correlate this with the findings of the immune cell subsets by means of immunohistochemistry (IHC).	—

Measure

Time frame

- To assess the T cell phenotype and activation - To assess the NK cell phenotype and activation - To measure the cytokine production by T cells - To determine Nuclear Factor kappa-B (NFkB) signaling in primary T cell subsets by means of flow cytometry. - Correlation of the findings in previously obtained peripheral lung biopsies; in order to clinico-pathologically correlate this with the findings of the immune cell subsets by means of immunohistochemistry (IHC).

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Countries

Netherlands

Outcome results