Neutrophil Extracellular Traps Formation Post-hematopoietic Stem Cell Transplantation (NETs post HSCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Tel-Aviv Sourasky Medical Center
Sponsor:
Collaborators:
Max Planck Institute for Infection Biology
Meir Hospital, Kfar Saba, Israel
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01491230
First received: December 11, 2011
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

Identifying the post-transplantation phase wherein neutrophils recover their ability to release NETs could shed new light on the mechanism responsible for the increased susceptibility to infection among these patients and aid in improving their prophylactic antimicrobial treatment. Therefore, we aim to examine neutrophil extracellular traps (NETs) formation, in relation to other neutrophil functions like chemotaxis, superoxide production, hydrogen peroxide production, and the presence of myeloperoxidase, in pediatric patients undergoing autologous and allogeneic hematopoietic stem cell transplantation (HSCT).


Condition
Childhood Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neutrophil Extracellular Traps (NETs) Formation Post-hematopoietic Stem Cell Transplantation (HSCT) and Its Relation to Chemotaxis and Creation of Reactive Oxygen Species

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Biospecimen Retention:   Samples Without DNA

10cc of peripheral venous blood will be collected from each patient at several time points: Before transplant, at neutrophil engraftment, 6 weeks, 3 months, 4 months, 6 months, 9 months, 1 year, 1.5 years, 2 years, and 3 years post-transplant, or until normalization of NETs formation in 2 consecutive examinations.


Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
25 autologous/25 allogeneic patients

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:

  1. Demographics.
  2. Tumor histological type, staging, previous chemotherapy regimen, and initial response to treatment.
  3. 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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Infants, children and adolescents undergoing autologous and allogeneic HSCT at the pediatric hemato-oncology departement of Dana children's Hospital, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491230

Contacts
Contact: Sivan Achituv, MD 972-3-6974270 sivanbrg@netvision.net.il
Contact: Ronit Elhasid, MD 972-3-6974252 ronite@tasmc.health.gov.il

Locations
Israel
Dana Children's Hospital, Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Contact: Sivan Achituv, MD    972-3-6974270    sivanbrg@netvision.net.il   
Principal Investigator: Sivan Achituv, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Max Planck Institute for Infection Biology
Meir Hospital, Kfar Saba, Israel
Investigators
Principal Investigator: Sivan Achituv, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Michal Roll PhD,MBA, Director, Division of Research and Developement, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01491230     History of Changes
Other Study ID Numbers: 0443-11-TLV
Study First Received: December 11, 2011
Last Updated: December 12, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
cancer
neutrophil extracellular traps
autologous hematopoietic stem cell transplantation
allogeneic hematopoietic stem cell transplantation
chemotaxis
superoxide production
hydrogen peroxide production
myeloperoxidase

ClinicalTrials.gov processed this record on October 23, 2014