NCT05963295

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

July 19, 2023

Last Update Submit

July 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • toxoplasma IgG

    rising titre

    1 year

Study Arms (2)

patient with hematlolgical malignancies

ACTIVE COMPARATOR
Diagnostic Test: toxoplasma igG

control group

ACTIVE COMPARATOR
Diagnostic Test: toxoplasma igG

Interventions

toxoplasma igGDIAGNOSTIC_TEST

Dignosis of toxoplasma

Also known as: toxoplasma IgM
control grouppatient with hematlolgical malignancies

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients with other non hematological malignancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 37288576BACKGROUND
  • 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.

    PMID: 33046380BACKGROUND
  • 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.

    PMID: 30708042BACKGROUND
  • 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.

    PMID: 32822769BACKGROUND

MeSH Terms

Conditions

Toxoplasmosis

Condition Hierarchy (Ancestors)

CoccidiosisProtozoan InfectionsParasitic DiseasesInfections

Central Study Contacts

nourhan m abd elhaliem, resident

CONTACT

Ahmed a allam, assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident-clinical pathology sohag university hospital

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 27, 2023

Study Start

August 1, 2023

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations