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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05963295
Collaborator
(none)
50
1
2
18.1
2.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: toxoplasma igG
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Toxoplasma Gondii Infection in Both Children and Adult Patients With Hematological Malignancies
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: patient with hematlolgical malignancies

Diagnostic Test: toxoplasma igG
Dignosis of toxoplasma
Other Names:
  • toxoplasma IgM
  • Active Comparator: control group

    Diagnostic Test: toxoplasma igG
    Dignosis of toxoplasma
    Other Names:
  • toxoplasma IgM
  • Outcome Measures

    Primary Outcome Measures

    1. toxoplasma IgG [1 year]

      rising titre

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag university Hospital Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Norhan Mohamed Abdelhalim, resident-clinical pathology sohag university hospital, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05963295
    Other Study ID Numbers:
    • Soh-Med-23-07-16MS
    First Posted:
    Jul 27, 2023
    Last Update Posted:
    Jul 27, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 27, 2023