ClinicalTrials.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

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
3 Years to 70 Years
Sex
All
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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.

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Conditions studied

  • Toxoplasmosis

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03

In context

Toxoplasmosis

29 studies on the registry are indexed under Toxoplasmosis; 8 are open to participants now.

This study's planned enrollment of 50 is below the median of 66 across 15 interventional studies indexed under Toxoplasmosis.

Browse Toxoplasmosis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • This study will be conducted on a group of patients who are diagnosed as have hematological

Exclusion criteria

Exclusion Criteria:

  • Patients with other non hematological .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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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

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What researchers measure

Primary outcomes

  1. toxoplasma IgG

    rising titre

    Time frame: 1 year

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Study locations

1 site
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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

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2023; primary completion for Feb 2025, 18 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2023
First posted
Jul 27, 2023
StartEst.
Aug 2023
Primary completionEst.
Feb 2025
CompletionEst.
Feb 2025
Last update
Jul 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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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Discussion

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