Neutrophil Extracellular Traps (NETs) Formation Following Chemotherapy and Their Role in Antitumor Activity

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Collaborators:
Max Planck Institute for Infection Biology
Meir Medical Center
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01533779
First received: February 12, 2012
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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 chemotherpy for solid and hematological malignancies. This data 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.

NETs formation against tumor cell lines and their ability to kill tumor cells will also be examined. The finding of NETs activity against tumor cells could have a major contribution to the investigators understanding of the function of the immune system against cancer.


Condition
Pediatric Solid Malignancies
Pediatric Hematological Malignancies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neutrophil Extracellular Traps (NETs) Formation Following Chemotherapy for Pediatric Hematological and Solid Tumors, and Its Relation to Other Neutrophil Functions and the Role of NETs in Antitumor Activity

Resource links provided by NLM:


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

Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Neutrophil function, including NETs formation, chemotaxis, superoxide production, hydrogen peroxide production, and the presence of myeloperoxidase, will be examined in 50 pediatric patientsundergoing chemotherapy for solid and hematological malignancies. Children with the following malignancies will be examined: acute lymphoblastic leukemia,acute myelogenous leukemia,Hodgkin's lymphoma,non-Hodgkin's lymphoma, primary bone sarcoma,rhabdomyosarcoma,non-rhabdomyosarcoma,neuroblastoma,Wilms' tumor,hepatoblastoma or hepatocellular carcinoma,germ cell tumors, and hystiocytosis. Also those with brain tumors such as medulloblastom,low grade glioma,high grade glioma,ependymoma,and embryonal and pineal region tumors. Data gathered on the patients will include background data (age, gender, ethnicity) and background diseases, data on current illness (histologic type, grade, stage, response treatment,infectious episodes), and on the use of ranulocyte-colony stimulating factor (G-CSF).

The following time points will be examined:

  1. At diagnosis, before initiation of chemotherapy.
  2. immediately before the 2nd course.
  3. After the middle course.
  4. A month after the last course.
  5. Three months after the last course.
  6. In acute myelogenous leukemia and acute lymphoblastic leukemia,time points also include the middle of the maintenance course and 3 months after the end of maintenance.

An additional blood examination will be used to examine NETs formation against tumor cell lines and their ability to kill tumor cells.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

All pediatric patients from birth to 21 years, male and female, undergoing chemotherapy treatment for solid and hematological malignancies.

Criteria

Inclusion Criteria:

Included in the study were patients with:

  • Acute lymphoblastic leukemia or acute myelogenous leukemia.
  • Hodgkin's lymphoma or non-Hodgkin's lymphoma.
  • Primary bone sarcoma, rhabdomyosarcoma, non-rhabdomyosarcoma, neuroblastoma, Wilms' tumor, hepatoblastoma or hepatocellular carcinoma, hystiocytosis, and germ cell tumors.
  • Medulloblastoma, low grade glioma, high grade glioma, ependymoma, and embryonal and pineal region tumors.

Exclusion Criteria:

  • A severe background disease that may affect Neutrophil function (e.g., diabetes, lupus).
  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: NCT01533779

Contacts
Contact: Sivan Achituv, MD 972-527360718 sivanbrg@netvision.net.il
Contact: Ronit Elhasid, MD 972-3-6974252 ronite@tasmc.health.gov.il

Locations
Israel
Department of pediatric hemato-oncology, Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Contact: Sivan Achituv, MD    972-527360718    sivanbrg@netvision.net.il   
Contact: Ronit Elhasid, MD    972-3-6974252    ronite@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Max Planck Institute for Infection Biology
Meir Medical Center
Investigators
Principal Investigator: Sivan Achituv, MD The department of pediatric hemato-oncology, Dana Childrens' Hospital, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01533779     History of Changes
Other Study ID Numbers: 0592-11-TLV
Study First Received: February 12, 2012
Last Updated: February 14, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
children
malignancy
neutrophil
neutrophil extracellular traps
superoxide production
hydrogen peroxide production
chemotaxis
myeloperoxidase
immunosurveillance
cancer cell lines

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014