NCT01533779

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

3 years

First QC Date

February 12, 2012

Last Update Submit

February 14, 2012

Conditions

Keywords

childrenmalignancyneutrophilneutrophil extracellular trapssuperoxide productionhydrogen peroxide productionchemotaxismyeloperoxidaseimmunosurveillancecancer cell lines

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of pediatric hemato-oncology, Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

MeSH Terms

Conditions

NeoplasmsChemotaxis

Condition Hierarchy (Ancestors)

Taxis ResponseBehavior, AnimalBehaviorOrientation, SpatialSpatial Behavior

Study Officials

  • Sivan Achituv, MD

    The department of pediatric hemato-oncology, Dana Childrens' Hospital, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2012

First Posted

February 15, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 15, 2012

Record last verified: 2012-02

Locations