NCT01491230

Brief Summary

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).

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 Dec 2011

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

December 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

3 years

First QC Date

December 11, 2011

Last Update Submit

December 12, 2011

Conditions

Keywords

cancerneutrophil extracellular trapsautologous hematopoietic stem cell transplantationallogeneic hematopoietic stem cell transplantationchemotaxissuperoxide productionhydrogen peroxide productionmyeloperoxidase

Study Arms (1)

25 autologous/25 allogeneic patients

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • All infants, children and adolescents undergoing autologous and allogeneic HSCT at the pediatric hemato-oncology departement of Dana children's Hospital.

You may not qualify if:

  • Severe background diseases (like diabetes and lupus) that there is no data in the literature on their influence on NETs production.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Children's Hospital, Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

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.

MeSH Terms

Conditions

NeoplasmsChemotaxis

Condition Hierarchy (Ancestors)

Taxis ResponseBehavior, AnimalBehaviorOrientation, SpatialSpatial Behavior

Study Officials

  • Sivan Achituv, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Research and Developement

Study Record Dates

First Submitted

December 11, 2011

First Posted

December 13, 2011

Study Start

December 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations