NCT05697224

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

First Submitted

Initial submission to the registry

January 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 15, 2023

Last Update Submit

January 15, 2023

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • use micro RNAas adiagnostic test for early diagnosis of shistosomal bladder cancer

    Sha-mir-71a could be a biomarker with diagnostic and prognostic value

    one year

Study Arms (2)

chronicurinary schistosomiasis

ACTIVE COMPARATOR
Diagnostic Test: urinary micro RNA detection

bladder cancer diseased patients

ACTIVE COMPARATOR
Diagnostic Test: urinary micro RNA detection

Interventions

urinary micro RNA detectionDIAGNOSTIC_TEST

Urinary Sha-miR-71a gene expression analysis Total RNA extraction and purification Sha-miR\_71a gene expression analysis MAPK-3 gene expression analysis

bladder cancer diseased patientschronicurinary schistosomiasis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PMID: 30207593BACKGROUND

  • Eissa S, Matboli M, Essawy NO, Kotb YM. Integrative functional genetic-epigenetic approach for selecting genes as urine biomarkers for bladder cancer diagnosis. Tumour Biol. 2015 Dec;36(12):9545-52. doi: 10.1007/s13277-015-3722-6. Epub 2015 Jul 3.

    PMID: 26138586BACKGROUND

  • Abd El-Aal AA, Bayoumy IR, Basyoni MM, Abd El-Aal AA, Emran AM, Abd El-Tawab MS, Badawi MA, Zalat RM, Diab TM. Genomic instability in complicated and uncomplicated Egyptian schistosomiasis haematobium patients. Mol Cytogenet. 2015 Jan 22;8(1):1. doi: 10.1186/s13039-014-0104-5. eCollection 2015.

    PMID: 25628757BACKGROUND

  • Chen L, Yuan L, Wang G, Cao R, Peng J, Shu B, Qian G, Wang X, Xiao Y. Identification and bioinformatics analysis of miRNAs associated with human muscle invasive bladder cancer. Mol Med Rep. 2017 Dec;16(6):8709-8720. doi: 10.3892/mmr.2017.7726. Epub 2017 Oct 4.

    PMID: 28990088BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

esraa o ali, assistant lecturer

CONTACT

01142171590esraa.ismail@med.sohag.edu.eg

hanaa a hady, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturar at parasitology department

Study Record Dates

First Submitted

January 15, 2023

First Posted

January 25, 2023

Study Start

February 1, 2023

Primary Completion

February 1, 2024

Study Completion

May 1, 2024

Last Updated

January 25, 2023

Record last verified: 2023-01