## Protocol Section
### Identification Module
**NCT ID:** NCT01533779

**Brief Title:** Neutrophil Extracellular Traps (NETs) Formation Following Chemotherapy and Their Role in Antitumor Activity

**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

#### Organization Study ID Info
**ID:** 0592-11-TLV
#### Organization
**Class:** OTHER_GOV
**Full Name:** Tel-Aviv Sourasky Medical Center
### Status Module
#### Completion Date
**Date:** 2015-02

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2012-02-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-02-14

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2015-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2012-02

**Status Verified Date:** 2012-02

#### Study First Post Date
**Date:** 2012-02-15
**Type:** ESTIMATED
**Study First Submit Date:** 2012-02-12
**Study First Submit QC Date:** 2012-02-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Max Planck Institute for Infection Biology

**Class:** OTHER

**Name:** Meir Medical Center

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Tel-Aviv Sourasky Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Pediatric Solid Malignancies

- Pediatric Hematological Malignancies

**Keywords:**

- children

- malignancy

- neutrophil

- neutrophil extracellular traps

- superoxide production

- hydrogen peroxide production

- chemotaxis

- myeloperoxidase

- immunosurveillance

- cancer cell lines

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Eligibility Module

**Eligibility 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).

**Healthy Volunteers:** True

**Maximum Age:** 21 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sivanbrg@netvision.net.il

**Name:** Sivan Achituv, MD

**Phone:** 972-527360718

**Role:** CONTACT

**Contact 2:**

**Email:** ronite@tasmc.health.gov.il

**Name:** Ronit Elhasid, MD

**Phone:** 972-3-6974252

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tel-Aviv

**Contacts:**

***Contact 1:***

- **Email:** sivanbrg@netvision.net.il

- **Name:** Sivan Achituv, MD

- **Phone:** 972-527360718

- **Role:** CONTACT

***Contact 2:***

- **Email:** ronite@tasmc.health.gov.il

- **Name:** Ronit Elhasid, MD

- **Phone:** 972-3-6974252

- **Role:** CONTACT

**Country:** Israel

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

**Status:** RECRUITING

**Zip:** 64239

#### Overall Officials

**Official 1:**

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

**Name:** Sivan Achituv, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000006402

- Term: Hematologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M21314

- Name: Hematologic Neoplasms

- Relevance: HIGH

- As Found: Hematological Malignancies

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

- ID: D000019337

- Term: Hematologic Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9918

- Name: Hydrogen Peroxide

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
