Neutrophil Extracellular Traps (NETs) Formation Following Chemotherapy and Their Role in Antitumor Activity
Recruitment status was: Recruiting
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.
Pediatric Solid Malignancies
Pediatric Hematological Malignancies
|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|
|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)|
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:
- At diagnosis, before initiation of chemotherapy.
- immediately before the 2nd course.
- After the middle course.
- A month after the last course.
- Three months after the last course.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533779
|Contact: Sivan Achituv, MDfirstname.lastname@example.org|
|Contact: Ronit Elhasid, MDemail@example.com|
|Department of pediatric hemato-oncology, Tel-Aviv Sourasky Medical Center||Recruiting|
|Tel-Aviv, Israel, 64239|
|Contact: Sivan Achituv, MD 972-527360718 firstname.lastname@example.org|
|Contact: Ronit Elhasid, MD 972-3-6974252 email@example.com|
|Principal Investigator:||Sivan Achituv, MD||The department of pediatric hemato-oncology, Dana Childrens' Hospital, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel|