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Spots Global Cancer Trial Database for Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant

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Trial Identification

Brief Title: Studying Blood Samples in Young Patients With Cytopenia After a Donor Stem Cell Transplant

Official Title: Serial Analysis of Chimerism in Patients With Refractory Cytopenia (RC) Transplanted With Reduced Intensity Conditioning (RIC)

Study ID: NCT00898118

Study Description

Brief Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at blood samples in young patients with cytopenia after undergoing a donor stem cell transplant.

Detailed Description: OBJECTIVES: Primary * To study hematopoietic chimerism in whole blood and different cell populations (i.e., CD14, CD15, CD 56, CD3, and CD19) as well as in dendritic cells and regulatory T cells after allogeneic hematopoietic stem cell transplantation with reduced intensity conditioning in patients with refractory cytopenia. * To compare the results of chimerism obtained with standard short tandem nucleotide polymorphism PCR (sensitivity 1%) with those obtained with single nucleotide polymorphisms PCR (sensitivity 0.1- 0.01%). Secondary * To evaluate the relationship between mixed chimerism and hematological engraftment, overall survival, and event-free survival. * To study the impact of mixed chimerism in plasmacytoid dendritic and regulatory T cells on the incidence of acute and chronic graft-versus-host-disease. OUTLINE: This is a multicenter study. Peripheral blood is collected from patients and donors prior to hematopoietic stem cell transplantation (HSCT). Patients also undergo blood sample collection on days 30, 60, 100, and 180 after transplantation. Peripheral blood cells are enriched and separated into lineage-specific subpopulations (i.e., CD3, CD14, CD15, CD19, and CD56) which are then divided equally for either DNA isolation via PCR or for flow cytometry. DNA concentrations in pre-HSCT donor and patient samples and in post-HSCT subpopulation samples are determined using quantitative real-time PCR. Samples are also analyzed for quantification of chimerism and detection of genetic markers via short tandem repeats- and sequence nucleotide polymorphism-based chimerism analyses.

Eligibility

Minimum Age:

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

St. Anna Children's Hospital, Vienna, , Austria

Ghent University, Ghent, , Belgium

University Hospital Motol, Prague, , Czech Republic

Aarhus Universitetshospital - Aarhus Sygehus, Aarhus, , Denmark

European Working Group of MDS in Childhood, Freiburg, , Germany

Universitaetskinderklinik - Universitaetsklinikum Freiburg, Freiburg, , Germany

IRCCS "Casa Sollievo della Sofferenza", South Giovanni Rotondo, , Italy

Erasmus MC - Sophia Children's Hospital, Rotterdam, , Netherlands

Akademia Medyczna im. Piastow Slaskich, Wroclaw, , Poland

University Children's Hospital, Zurich, , Switzerland

Contact Details

Name: Peter Bader, MD

Affiliation: European Working Group of MDS in Childhood

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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