CClinicalTrials.gg
Not yet recruitingNCT05963295Updated Jul 27, 2023

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

An interventional study of toxoplasma igG in Toxoplasmosis, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 3 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Sohag University · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
3 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Toxoplasmosis
03

Who can participate

Ages eligible
3 Years to 70 Years
Sexes eligible
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

Exclusion Criteria:

  • Patients with other non hematological malignancies.
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    patient with hematlolgical malignancies

    Diagnostic Test: toxoplasma igG

  • Active comparator
    control group

    Diagnostic Test: toxoplasma igG

Interventions

  • Diagnostic testtoxoplasma igG

    Dignosis of toxoplasma

    Also known as: toxoplasma IgM

05

What researchers measure

Primary outcomes

  1. toxoplasma IgG

    rising titre

    Time frame: 1 year

06

Study locations

1 site
  • Sohag university Hospital
    Sohag, Egypt
    • Magdy M Amin, professor · Contact
07

References and documents

Publications

  • 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. PubMed 37288576 ↗
  • 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. PubMed 33046380 ↗
  • 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. PubMed 30708042 ↗
  • 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. PubMed 32822769 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT05963295
Lead sponsor
Sohag University
Responsible party
Norhan Mohamed Abdelhalim (resident-clinical pathology sohag university hospital, Sohag University) — Principal investigator
First posted
Jul 27, 2023
Start date
Aug 2023 (estimated)
Primary completion
Feb 2025 (estimated)
Completion
Feb 2025 (estimated)
Last update
Jul 27, 2023

Study contacts

nourhan m abd elhaliem, resident
Contact
norhanmohamed@med.sohag.edu.eg
01096779396
Ahmed a allam, assistant professor
Contact
01001636593

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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