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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05697224
• Other study ID #: soh-med-22-11-12
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: January 2023
• Source: Sohag University
• Contact: esraa o ali, assistant lecturer
• Phone: 01142171590
• Email: esraa.ismail[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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