Aschistosoma Haematobiumspecific microRNAas a Tumor Marker for Early Diagnosis and Prognosis of Bilharzial Bladder Cancer in Eygpt

January 15, 2023 updated by: Esraa Omar Ali, Sohag University

Role of Aschistosoma Haematobiumspecific microRNAas Atumor Marker for Early Diagnosis and Prognosis of Bilharzial Bladder Cancer in Eygpt

miRNAs have been detected in different bodily fluids, which suggests significant potential, such as their use as biomarkers in diagnostics and prognostics. Sha-mir-71a was abundantly found in the urine of patients with bladder cancer as compared to benign bladder cystitis associated with schistosomiasis . Additionally, this miRNA was more highly detected in urine samples from patients with bilharzial bladder cancer than bladder cancer not associated with bilharziasis (schistosomiasis), suggesting its specificity in the identification of bladder cancer associated with infection.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: hanaa a hady, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • urinary symptoms (hematuria, urinary retention, dysuria… etc.), who were planned to undergo cystoscopy for suspicion of bladder cancer (BC) or benign bilharzial cystitis (Bil), will be selected.

Exclusion Criteria:

  • : In bladder cancer group Patients who have received chemotherapy, or with previously diagnosed other malignancy within the past 5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: chronicurinary schistosomiasis
Diagnostic test: urinary micro RNA detection
Urinary Sha-miR-71a gene expression analysis Total RNA extraction and purification Sha-miR_71a gene expression analysis MAPK-3 gene expression analysis
Active Comparator: bladder cancer diseased patients
Diagnostic test: urinary micro RNA detection
Urinary Sha-miR-71a gene expression analysis Total RNA extraction and purification Sha-miR_71a gene expression analysis MAPK-3 gene expression analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
use micro RNAas adiagnostic test for early diagnosis of shistosomal bladder cancer
Time Frame: one year
Sha-mir-71a could be a biomarker with diagnostic and prognostic value
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

January 15, 2023

First Submitted That Met QC Criteria

January 15, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 15, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-med-22-11-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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