- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01491230
Neutrophil Extracellular Traps Formation Post-hematopoietic Stem Cell Transplantation (NETs post HSCT)
Neutrophil Extracellular Traps (NETs) Formation Post-hematopoietic Stem Cell Transplantation (HSCT) and Its Relation to Chemotaxis and Creation of Reactive Oxygen Species
Study Overview
Status
Conditions
Detailed Description
Although neutrophil engraftment takes place 10 to 14 days after autologous HSCT, and 15 to 30 days after allogeneic HSCT, using an ablative conditioning regimen, neutrophil dysfunction may persist for longer periods. Relatively scant data exists on neutrophil function following HSCT. After autologous HSCT, the respiratory burst and phagocytosis may be decreased for up to 3 months. After allogeneic HSCT, respiratory burst and chemotaxis are generally decreased for 4 to 6 months. Factors such as continuation of chemotherapy, immunosuppression, and GVHD contribute to this prolonged dysfunction. No data exist on reconstitution of NETs following HSCT.
Nets production and other neutrophil functions will be examined at several time points: before transplantation, at neutrophil engraftment, 6 weeks, 3 months, 6 months, 9 months, 1 year, 1.5 years, 2 years, and 3 years post-transplant, or until normalization of neutrophil function at 2 consecutive time points. Data gathered on patients will cover:
- Demographics.
- Tumor histological type, staging, previous chemotherapy regimen, and initial response to treatment.
- HSCT procedure - type of conditioning regimen, type of graft (autologous or allogeneic - related donor/unrelated donor/cord blood), use of bone marrow stem cells (SCs) or peripheral mobilized SCs, number of SCs given, post-transplant immunosuppression, post-transplant prophylactic antimicrobial treatment, infections during the study period, and GVHD occurrence and treatment.
Neutrophil examinations will be done in collaboration with the Laboratory for Leukocyte Function of the Department of Pediatrics, Meir Medical Center, Kfar Saba and NETs visualization with the Department of Cellular Microbiology at the Max Planck Institute for Infection Biology, Berlin.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ronit Elhasid, MD
- Phone Number: 972-3-6974252
- Email: ronite@tasmc.health.gov.il
Study Contact Backup
- Name: Sivan Achituv, MD
- Phone Number: 972-3-6974270
- Email: sivanbrg@netvision.net.il
Study Locations
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-
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Tel-Aviv, Israel, 64239
- Recruiting
- Dana Children's Hospital, Tel-Aviv Sourasky Medical Center
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Contact:
- Sivan Achituv, MD
- Phone Number: 972-3-6974270
- Email: sivanbrg@netvision.net.il
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Principal Investigator:
- Sivan Achituv, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All infants, children and adolescents undergoing autologous and allogeneic HSCT at the pediatric hemato-oncology departement of Dana children's Hospital.
Exclusion Criteria:
- Severe background diseases (like diabetes and lupus) that there is no data in the literature on their influence on NETs production.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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25 autologous/25 allogeneic patients
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sivan Achituv, MD, Tel-Aviv Sourasky Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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