Back to resultsAschistosoma Haematobiumspecific microRNAas a Tumor Marker for Early Diagnosis and Prognosis of Bilharzial Bladder Cancer in Eygpt
Primary Purpose
Bladder Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
urinary micro RNA detection
Sponsored by
About this trial
This is an interventional diagnostic trial for Bladder Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
chronicurinary schistosomiasis
bladder cancer diseased patients
Arm Description
Outcomes
Primary Outcome Measures
use micro RNAas adiagnostic test for early diagnosis of shistosomal bladder cancer
Sha-mir-71a could be a biomarker with diagnostic and prognostic value
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05697224
Brief Title
Aschistosoma Haematobiumspecific microRNAas a Tumor Marker for Early Diagnosis and Prognosis of Bilharzial Bladder Cancer in Eygpt
Official Title
Role of Aschistosoma Haematobiumspecific microRNAas Atumor Marker for Early Diagnosis and Prognosis of Bilharzial Bladder Cancer in Eygpt
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chronicurinary schistosomiasis
Arm Type
Active Comparator
Arm Title
bladder cancer diseased patients
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
urinary micro RNA detection
Intervention Description
Urinary Sha-miR-71a gene expression analysis Total RNA extraction and purification Sha-miR_71a gene expression analysis MAPK-3 gene expression analysis
Primary Outcome Measure Information:
Title
use micro RNAas adiagnostic test for early diagnosis of shistosomal bladder cancer
Description
Sha-mir-71a could be a biomarker with diagnostic and prognostic value
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
esraa o ali, assistant lecturer
Phone
01142171590
Email
esraa.ismail@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
hanaa a hady, professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30207593
Citation
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. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313.
Results Reference
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PubMed Identifier
26138586
Citation
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.
Results Reference
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PubMed Identifier
25628757
Citation
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.
Results Reference
background
PubMed Identifier
28990088
Citation
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.
Results Reference
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Aschistosoma Haematobiumspecific microRNAas a Tumor Marker for Early Diagnosis and Prognosis of Bilharzial Bladder Cancer in Eygpt
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