NCT04834076

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.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

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

Study Start

First participant enrolled

June 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

April 4, 2021

Last Update Submit

January 12, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    up to 1 year

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

    IgG, IgM.

    up to 1 year

Study Arms (2)

Cancer patients

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

Diagnostic Test: ELISADiagnostic Test: PCRDiagnostic Test: Sequencing

Healthy controls

50 healthy controls will be recruited in the study.

Diagnostic Test: ELISADiagnostic Test: PCRDiagnostic Test: Sequencing

Interventions

ELISADIAGNOSTIC_TEST

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

Cancer patientsHealthy controls
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.

Cancer patientsHealthy controls
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.

Cancer patientsHealthy controls

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Hematologic cancers on treatment
  • Solid Cancers on treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospitals

Sohag, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

ToxoplasmosisNeoplasms

Interventions

Base Sequence

Condition Hierarchy (Ancestors)

CoccidiosisProtozoan InfectionsParasitic DiseasesInfections

Intervention Hierarchy (Ancestors)

Molecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresGenetic Phenomena

Study Officials

  • Eman FF Mohammed, Ass lecturer

    Sohag University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman FF Mohammed, Ass lecturer

CONTACT

Mohammed EM Tolba, Prof Dr

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant of medical parasitology

Study Record Dates

First Submitted

April 4, 2021

First Posted

April 6, 2021

Study Start

June 1, 2020

Primary Completion

January 30, 2021

Study Completion

December 1, 2022

Last Updated

January 13, 2022

Record last verified: 2022-01

Locations