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Genetic Diversity of Toxoplasma Gondii in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04834076
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Eman Fathi Fadel Mohammed, Sohag University

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

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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


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.




Primary Outcome Measures :
  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. [ Time Frame: up to 1 year ]
    Using PCR and DNA sequencing

  2. 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.


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

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
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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