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Toxoplasma Gondii InfectionNCT04834076

Genetic Diversity of Toxoplasma Gondii in Cancer Patients

An observational study of Toxoplasma Gondii Infection and Cancer, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

I. Evaluation of T. gondii infection in cancer patients using different serological markers. II. Studying genetic lineages infecting cancer patients in Sohag Governorate to predict clinical course and therapeutic needs using B1 and RE genes. Read more about this study

Who is it for?
Ages 1 year and olderHealthy volunteers can take part
Conditions the study is for
Toxoplasma Gondii Infection, Cancer
What is being tested?
ELISA, PCR and Sequencing
How many people
100 participants
Where
1 siteEgypt
Study dates
1 Jun 2020to Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: 50 cancer patients referred to the Oncology Department, Faculty of medicine, Sohag University and 20 healthy controls will be recruited in the study. Relevant demographic and clinical data will be obtained from all participants. Written consents will be obtained from each participant after clear full explanation about the procedures and their significance.

Who may be able to join

  • Hematologic cancers on treatment
  • Solid Cancers on treatment

Who cannot join

  • Patients with other immune compromise states eg. DM, autoimmune diseases
  • Patients who are HIV positive

Trial locations and contacts

1 site in 1 country.

Eman FF Mohammed, Ass lecturer contact

201066209796

emanfathy@med.sohag.edu.eg

Mohammed EM Tolba, Prof Dr contact

201006329838

essa3g@aun.edu.eg

Egypt1 site, 1 recruiting
  • Sohag University Hospitals

    Sohag

    Eman FF Mohammed, MSc

    Recruiting

Other trials in Egypt

About this study

  1. Evaluation of T. gondii infection in cancer patients using different serological markers.

II. Studying genetic lineages infecting cancer patients in Sohag Governorate to predict clinical course and therapeutic needs using B1 and RE genes.

Read the detailed description

The global cancer burden is estimated to have risen to 18.1 million new cases and 9.6 million deaths in 2018. Patients with cancer have deficient cellular immunity and are potentially susceptible to opportunistic infections including Toxoplasma gondii (T. gondii). Few reports are available about toxoplasmosis in this group of patients. In recent years, it has emerged as an important life-threatening opportunistic pathogen in immunocompromised patients.

  1. gondii is a ubiquitous obligate intracellular protozoan parasite that can infect virtually any nucleated vertebrate cell. T. gondii is one of the most successful parasites worldwide, with upwards of 30% of the human population infected.

While T. gondii infection in immunocompetent individuals is usually asymptomatic, it is more detrimental in immunocompromised individuals, such as those with HIV, patients receiving organ transplants or undergoing cancer treatment. A variety of malignancies, including lymphoma, leukemia, and myeloma, can reactivate toxoplasmosis. Moreover, T. gondii is incriminated to be responsible for the progression of malignant diseases.

Screening of toxoplasmosis in cancer patients is mandatory to guard against life-threatening disseminated disease. Diagnosis rely mainly on serology. A study in 2018 was performed to assess the prevalence of anti-T. gondii antibody among cancer patients in Cairo-Egypt. Among 180 cancer patients, a total of 110 patients (61.1%) were positive for anti-T. gondii antibodies. Till now there is no screening program in Egypt for toxoplasmosis in cancer patients although recently demonstrated to be at high risk for acquiring the infection with life-threatening sequelae.

Despite the significant improvements in serological methods, there are still unresolvable limitations such as inability of these methods to confirm the presence of parasite in immunocompromised patients. To overcome these limitations, different molecular methods including conventional PCR (cn PCR), nested PCR, real-time PCR (qPCR) and also loop-mediated isothermal amplification (LAMP) techniques have been developed to detect T. gondii DNA in biological samples.

As molecular diagnosis is not depending on the immunological condition of the host, it would be ideal for cancer patients. The ability of molecular methods to detect low amounts of parasites in fluids or tissues is a key issue, as Toxoplasma can circulate at low concentrations, or inconstantly.

  1. gondii has been considered a single species in the genus Toxoplasma. Early studies on the parasite strains from North America and Europe identified limited genetic diversity, which were classified into three clonal lineages I, II, and III.

Genotyping of isolates from all continents revealed a complex population structure. Recent research supports the notion that T. gondii genotype may be associated with disease severity. The outcome of toxoplasmosis is related primarily to host and parasite genetics.

The first PCR technique for T. gondii detection was established by Burg and colleagues in which the 35-repeat B1 gene of T. gondii genome was amplified. Following it, several multi-copy targeting genes including 18S rRNA-, P30-,529-bp repeat fragment or the AF146527 element have been used for the detection of T. gondii in different biological samples.

In spite of the growing data concerning T. gondii genotypes and its role in epidemiological and biological studies,very few studies have been reported in Egypt until now. It is essential to genetically define and characterize T. gondii strains isolated from cancer patients to understand the population genetic structure, population biology, and pathogenesis of this important pathogen in our locality using the highly sensitive molecular techniques.

To the best of our knowledge, this is the first study in Egypt to reveal the population structure of T. gondii in patients with cancer.

Being tested
ELISA, PCR, Sequencing
Medical subject headings
Toxoplasmosis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ELISADiagnostic test

    ELISA is is a test that detects and measures toxoplasma IgG and IgM antibodies in blood.

  • PCRDiagnostic test

    Polymerase chain reaction (PCR) is a method widely used to rapidly make millions to billions of copies of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it to a large enough amount to study in detail.

  • SequencingDiagnostic test

    DNA sequencing is a laboratory technique used to determine the exact sequence of bases (A, C, G, and T) in a DNA molecule. The DNA base sequence carries the information a cell needs to assemble protein and RNA molecules. DNA sequence information is important to scientists investigating the functions of genes.

Study groups in NCT04834076
Study groupRoleWhat they receive
Cancer patients50 cancer patients referred to the Oncology Department, Faculty of medicine, Sohag University.
Receives: Diagnostic Test: ELISA; Diagnostic Test: PCR; Diagnostic Test: Sequencing
Healthy controls50 healthy controls will be recruited in the study.
Receives: Diagnostic Test: ELISA; Diagnostic Test: PCR; Diagnostic Test: Sequencing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Isolation and genotyping of T. gondii from blood of Cancer patients in Sohag Governorate, Egypt using PCR and DNA sequencing of Toxoplasma gondii B1 & RE genes.

    Using PCR and DNA sequencing

    Measured: up to 1 year

  2. Evaluation of T. gondii infection in cancer patients using ELISA.

    IgG, IgM.

    Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2021
  2. Study start1 Jun 2020
  3. Primary completion30 Jan 2021
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04834076
Sponsor's protocol ID
Toxoplasma gondii genomics
Status last verified
Jan 2022
First submitted
4 Apr 2021
Last updated
13 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fadel EF, Tolba MEM, Ahmed AM, El-Hady HA. Serological and molecular detection of Toxoplasma Gondii among cancer patients in Sohag, Upper Egypt: a case-control study. Sci Rep. 2025 Feb 12;15(1):5236. doi: 10.1038/s41598-025-88680-3.

    PubMed 39939648

Questions about this trial

What is this clinical trial studying?

An observational study of Toxoplasma Gondii Infection and Cancer, run by Sohag University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eman FF Mohammed, Ass lecturer (201066209796, emanfathy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Isolation and genotyping of T. gondii from blood of Cancer patients in Sohag Governorate, Egypt using PCR and DNA sequencing of Toxoplasma gondii B1 & RE genes. (time frame: up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04834076, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.

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