Ignite Creation Date:
2024-05-05 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499070
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2007-07-10
Brief Title:
Assessing Immune Function in Young Patients With Cytopenia That Did Not Respond to Treatment
Sponsor:
University Hospital Freiburg
Organization:
University Hospital Freiburg
Study Overview
Official Title:
TCR Vbeta Repertoire and PNH Clones in Children With Refractory Cytopenia RC An Open Nonrandomised Multi-Center Prospective Study
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Studying biopsy bone marrow and blood samples from patients with cytopenia that did not respond to treatment may help doctors learn more about the disease and plan the best treatment
PURPOSE This laboratory study is assessing immune function in young patients with cytopenia that did not respond to treatment
PURPOSE This laboratory study is assessing immune function in young patients with cytopenia that did not respond to treatment
Detailed Description:
OBJECTIVES
Primary
To evaluate the value of TCR V beta repertoire analysis for the determination of autoimmunity in refractory cytopenia RC
To evaluate which immunophenotypic hematopoietic subclones are associated with oligoclonal T-cell expansion in RC
To evaluate the presence of paroxysmal nocturnal hemoglobinuria PNH clones in RC
Secondary
To compare the molecular response with the hematologic response in patients with RC after treatment with immunosuppressive therapy IST
To compare the molecular response with human leukocyte histocompatability antigen HLA expression in patients with RC after treatment with IST
OUTLINE This is an open-label multicenter nonrandomized prospective study
Patients undergo biopsy bone marrow and blood sample collection periodically for immunological studies Samples are analyzed for TCR V beta repertoire and paroxysmal nocturnal hemoglobinuria PNH clone analysis via PCR heteroduplex analysis and immunophenotyping of CD14 CD16 CD55 CD59 and CD24 expression via flow cytometry
Primary
To evaluate the value of TCR V beta repertoire analysis for the determination of autoimmunity in refractory cytopenia RC
To evaluate which immunophenotypic hematopoietic subclones are associated with oligoclonal T-cell expansion in RC
To evaluate the presence of paroxysmal nocturnal hemoglobinuria PNH clones in RC
Secondary
To compare the molecular response with the hematologic response in patients with RC after treatment with immunosuppressive therapy IST
To compare the molecular response with human leukocyte histocompatability antigen HLA expression in patients with RC after treatment with IST
OUTLINE This is an open-label multicenter nonrandomized prospective study
Patients undergo biopsy bone marrow and blood sample collection periodically for immunological studies Samples are analyzed for TCR V beta repertoire and paroxysmal nocturnal hemoglobinuria PNH clone analysis via PCR heteroduplex analysis and immunophenotyping of CD14 CD16 CD55 CD59 and CD24 expression via flow cytometry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EWOG-MDS-RC-06 | OTHER | University Hospital Freiburg | None |