Genetic Diversity of Toxoplasma Gondii in Cancer Patients

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ClinicalTrials.gov Identifier: NCT04834076

Recruitment Status : Unknown

Verified January 2022 by Eman Fathi Fadel Mohammed, Sohag University.
Recruitment status was: Recruiting

First Posted : April 6, 2021

Last Update Posted : January 13, 2022

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Sponsor:

Information provided by (Responsible Party):

Eman Fathi Fadel Mohammed, Sohag University

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Toxoplasma Gondii Infection Cancer	Diagnostic Test: ELISA Diagnostic Test: PCR Diagnostic Test: Sequencing

Show detailed description

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.

T. 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.

T. 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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	100 participants
Observational Model:	Case-Control
Time Perspective:	Retrospective
Official Title:	Genetic Diversity of Toxoplasma Gondii in Cancer Patients
Actual Study Start Date :	June 1, 2020
Actual Primary Completion Date :	January 30, 2021
Estimated Study Completion Date :	December 2022

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Coccidioidomycosis

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Cancer patients 50 cancer patients referred to the Oncology Department, Faculty of medicine, Sohag University.	Diagnostic Test: ELISA ELISA is is a test that detects and measures toxoplasma IgG and IgM antibodies in blood. Diagnostic Test: PCR 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. Diagnostic Test: Sequencing 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.
Healthy controls 50 healthy controls will be recruited in the study.	Diagnostic Test: ELISA ELISA is is a test that detects and measures toxoplasma IgG and IgM antibodies in blood. Diagnostic Test: PCR 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. Diagnostic Test: Sequencing 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.

Group/Cohort

Intervention/treatment

Cancer patients

50 cancer patients referred to the Oncology Department, Faculty of medicine, Sohag University.

Diagnostic Test: ELISA

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

Diagnostic Test: PCR

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.

Diagnostic Test: Sequencing

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.

Healthy controls

50 healthy controls will be recruited in the study.

Diagnostic Test: ELISA

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

Diagnostic Test: PCR

Diagnostic Test: Sequencing

Outcome Measures

Primary Outcome Measures :

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 ]
Using PCR and DNA sequencing
Evaluation of T. gondii infection in cancer patients using ELISA. [ Time Frame: up to 1 year ]
IgG, IgM.

Biospecimen Retention: Samples With DNA

Blood samples in EDTA tubes for molecular detection of Toxoplasma gondii gene then for sequencing.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	1 Year and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

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.

Criteria

Inclusion Criteria:

Hematologic cancers on treatment
Solid Cancers on treatment

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04834076

Contacts

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Contact: Eman FF Mohammed, Ass lecturer	201066209796	emanfathy@med.sohag.edu.eg
Contact: Mohammed EM Tolba, Prof Dr	201006329838	essa3g@aun.edu.eg

Locations

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Egypt
Sohag University Hospitals	Recruiting
Sohag, Egypt
Principal Investigator: Eman FF Mohammed, MSc

Sponsors and Collaborators

Sohag University

Investigators

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Principal Investigator:	Eman FF Mohammed, Ass lecturer	Sohag University

More Information

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Responsible Party:	Eman Fathi Fadel Mohammed, Teaching assistant of medical parasitology, Sohag University
ClinicalTrials.gov Identifier:	NCT04834076
Other Study ID Numbers:	Toxoplasma gondii genomics
First Posted:	April 6, 2021 Key Record Dates
Last Update Posted:	January 13, 2022
Last Verified:	January 2022

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Toxoplasmosis Coccidiosis Protozoan Infections Parasitic Diseases Infections

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