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Toxoplasma Gondii Infection in Both Children and Adult Patients With Hematological Malignancies

Primary Purpose

Toxoplasmosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
toxoplasma igG
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Toxoplasmosis

Eligibility Criteria

3 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: This study will be conducted on a group of patients who are diagnosed as have hematological malignancies Exclusion Criteria: Patients with other non hematological malignancies.

Sites / Locations

  • Sohag university Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

patient with hematlolgical malignancies

control group

Arm Description

Outcomes

Primary Outcome Measures

toxoplasma IgG
rising titre

Secondary Outcome Measures

Full Information

First Posted
July 19, 2023
Last Updated
July 19, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05963295
Brief Title
Toxoplasma Gondii Infection in Both Children and Adult Patients With Hematological Malignancies
Official Title
Toxoplasma Gondii Infection in Both Children and Adult Patients With Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Toxoplasmosis is one of the most common zoonotic diseases caused by the obligate intracellular parasite, T. gondii. It affects up to one-third of the world's population Horizontal transmission is mostly caused by ingestion of tissue cysts in infected meat, or through consumption of food or drink contaminated with sporulated oocysts, while vertical transmission occurs due to primary acquired maternal infection throughout pregnancy.In immunocompetent hosts, acquired infection is asymptomatic in more than 80% of cases, or is associated with fever,cervical lymphadenopathy, or myalgia. In immunocompromised patients,toxoplasmosis is always life-threatening where toxoplasmic encephalitis is the most important presentation. Among those patients, the disease may be caused by a newly acquired infection, reactivation following cyst rupture, donation of a cyst-containing organ from a seropositive donor to a seronegative recipient, or reactivation of dormant infection in the recipient Patients with hematological malignancy (HM), including those with acute myelogenous leukemia, and those who have undergone hematopoietic stem cell transplantation or treated with aggressive immunosuppressive regimens are at high risk of opportunistic infections The association between toxoplasmosis and cancers remains dual. Most cancer patients are in a state of impaired cellular and humoral immune systems either from the primary disease, or from chemotherapy and/or radiotherapy administration. Chemotherapeutic drugs work by killing both fast growing cancer cells, and healthy white blood cells causing neutropenia. So, patients receiving chemotherapy are more susceptible to Toxoplasma infections. Many studies have reported that the rate of reactivation of a latent T. gondii infection was higher in different types of cancers particularly those of the eye, brain, blood and breast. On the other side, T. gondii was also implicated as possible oncogenic pathogen with suggested role in induction and progression of malignant diseases. This was explained by many theories such as preventing apoptosis, enhancing the motility of dendritic cells and macrophages.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxoplasmosis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patient with hematlolgical malignancies
Arm Type
Active Comparator
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
toxoplasma igG
Other Intervention Name(s)
toxoplasma IgM
Intervention Description
Dignosis of toxoplasma
Primary Outcome Measure Information:
Title
toxoplasma IgG
Description
rising titre
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: This study will be conducted on a group of patients who are diagnosed as have hematological malignancies Exclusion Criteria: Patients with other non hematological malignancies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nourhan m abd elhaliem, resident
Phone
01096779396
Email
norhanmohamed@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed a allam, assistant professor
Phone
01001636593
Facility Information:
Facility Name
Sohag university Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
37288576
Citation
Elzeny H, Mohamed W, Daef E, El-Badawy O, Shaaban L, Osman NS, Hadiya S, Aly S. Detection of multiple extensively-drug resistant hypervirulent Klebsiella pneumoniae clones from patients with ventilator-associated pneumonia in Egypt. J Med Microbiol. 2023 Jun;72(6). doi: 10.1099/jmm.0.001701.
Results Reference
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PubMed Identifier
33046380
Citation
Dupont D, Fricker-Hidalgo H, Brenier-Pinchart MP, Garnaud C, Wallon M, Pelloux H. Serology for Toxoplasma in Immunocompromised Patients: Still Useful? Trends Parasitol. 2021 Mar;37(3):205-213. doi: 10.1016/j.pt.2020.09.006. Epub 2020 Oct 9.
Results Reference
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PubMed Identifier
30708042
Citation
Anvari D, Sharif M, Sarvi S, Aghayan SA, Gholami S, Pagheh AS, Hosseini SA, Saberi R, Chegeni TN, Hosseininejad Z, Daryani A. Seroprevalence of Toxoplasma gondii infection in cancer patients: A systematic review and meta-analysis. Microb Pathog. 2019 Apr;129:30-42. doi: 10.1016/j.micpath.2019.01.040. Epub 2019 Jan 29.
Results Reference
background
PubMed Identifier
32822769
Citation
Kalantari N, Gorgani-Firouzjaee T, Hassani S, Chehrazi M, Ghaffari S. Association between Toxoplasma gondii exposure and hematological malignancies: A systematic review and meta-analysis. Microb Pathog. 2020 Nov;148:104440. doi: 10.1016/j.micpath.2020.104440. Epub 2020 Aug 19.
Results Reference
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Toxoplasma Gondii Infection in Both Children and Adult Patients With Hematological Malignancies

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