Possible Diagnostic Protein Markers in Schistosoma Related Bladder Diseases.
1 other identifier
observational
120
1 country
1
Brief Summary
Schistosomiasis is the second most common parasitic infection affecting humans, endemic in the Middle East, especially Egypt (1), and in 42 African countries (2). There are 5 main species infecting humans: S. mansoni, S. haematobium, S. japonicum, S. intercalatum, and S. mekongi. S. haematobium is responsible for chronic urogenital infections that may cause serious complications (3). Urinary schistosomiasis is mostly borne in rural and agricultural communities, according to WHO (4)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2023
Longer than P75 for all trials
1 active site
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
June 19, 2023
CompletedFirst Posted
Study publicly available on registry
July 12, 2023
CompletedStudy Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2027
ExpectedJuly 12, 2023
July 1, 2023
1.7 years
June 19, 2023
July 4, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
NF-kappa-B and Protein kinase Cα
Association and changes of NF-kappa-B and Protein kinase Cα as diagnostic markers in chronic schistosomaiasis with or without bladder cancer
2 years
heat shock protein
Changes of heat shock protein HSP 70 as urinary biomarkers for Schistosomal bladder diseases.
1 year
Study Arms (6)
Schistosoma haematobium cystitis.
patient has symptoms suggestive of Schistosoma haematobium infection like terminal hematuria and burning micturition
Healthy personnel.
as control group
Schistosomal bladder cancer.
from patient undergone diagnostic cystoscopy and sampling and confirmed pathologically as Schistosomal bladder cancer.
non Schistosomal bladder cancer.
from patient undergone diagnostic cystoscopy and sampling and confirmed pathologically as non Schistosomal bladder cancer.
Schistosomal cystitis patients.
from patient undergone diagnostic cystoscopy and sampling and confirmed pathologically as Schistosomal cystitis
healthy bladder tissue from tissue biopsy patient with benign prostatic hyperplasia.
as control group
Interventions
Tissue samples: * Histopathological examination: Hematoxylin and Eosin slides will be prepared and examined. * The only dependable criterion for the diagnosis of bilharzial infestation is the microscopic detection of Bilharzia ova in pathological sections. * Pathology (cystitis- cancer and its grade staging will be reported in accordance with the 2022 World Health Organization Classification of Tumors of the Urinary System (17). * To quantify levels of Nuclear factor kappa B and protein kinase c α: * Immunohistochemistry according to the manufacturer's instructions.
Urine samples: * Mic roscopic examination (detection of S. haematobium egg - egg counting) * Detection of HSP 70 Measurements: indirect ELISA will be used to quantify HSP concentrations in urine.
Eligibility Criteria
Male and female patients of different age groups known to suffer from cystitis and bladder cancer regardless results from schistosomal infection or any other causes.
You may qualify if:
- Male and female patients of different age groups known to suffer from cystitis and bladder cancer regardless results from schistosomal infection or any other causes.
You may not qualify if:
- patients with concomitant other tumours.
- patients with other urinary tract infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University Hospital
Asyut, Assiut University71515, Egypt
Related Publications (11)
Amin HAA, Kobaisi MH, Samir RM. Schistosomiasis and Bladder Cancer in Egypt: Truths and Myths. Open Access Maced J Med Sci. 2019 Dec 10;7(23):4023-4029. doi: 10.3889/oamjms.2019.857. eCollection 2019 Dec 15.
PMID: 32165946BACKGROUNDEfared B, Bako ABA, Idrissa B, Alhousseini D, Boureima HS, Sode HC, Nouhou H. Urinary bladder Schistosoma haematobium-related squamous cell carcinoma: a report of two fatal cases and literature review. Trop Dis Travel Med Vaccines. 2022 Feb 15;8(1):3. doi: 10.1186/s40794-022-00161-x.
PMID: 35164874BACKGROUNDNacif-Pimenta R, da Silva Orfano A, Mosley IA, Karinshak SE, Ishida K, Mann VH, Coelho PMZ, da Costa JMC, Hsieh MH, Brindley PJ, Rinaldi G. Differential responses of epithelial cells from urinary and biliary tract to eggs of Schistosoma haematobium and S. mansoni. Sci Rep. 2019 Jul 24;9(1):10731. doi: 10.1038/s41598-019-46917-y.
PMID: 31341177BACKGROUNDAl-Delaimy WK, Awadalla A, El-Assmy A, Abol-Enein H, Shokeir A. Comparison of urinary telomerase, CD44, and NMP22 assays for detection of bladder squamous cell carcinoma. Curr Urol. 2022 Sep;16(3):154-159. doi: 10.1097/CU9.0000000000000098. Epub 2022 Aug 2.
PMID: 36204357BACKGROUNDChen Z, Ding W, Xu K, Tan J, Sun C, Gou Y, Tong S, Xia G, Fang Z, Ding Q. The 1973 WHO Classification is more suitable than the 2004 WHO Classification for predicting prognosis in non-muscle-invasive bladder cancer. PLoS One. 2012;7(10):e47199. doi: 10.1371/journal.pone.0047199. Epub 2012 Oct 17.
PMID: 23082147BACKGROUNDEissa S, Matboli M, Shawky S, Essawy NO. Urine biomarkers of schistosomiais and its associated bladder cancer. Expert Rev Anti Infect Ther. 2015 Aug;13(8):985-93. doi: 10.1586/14787210.2015.1051032. Epub 2015 Jun 23.
PMID: 26105083BACKGROUNDEl-Meghawry El-Kenawy A, El-Kott AF, Hasan MS. Heat shock protein expression independently predicts survival outcome in schistosomiasis-associated urinary bladder cancer. Int J Biol Markers. 2008 Oct-Dec;23(4):214-8. doi: 10.1177/172460080802300403.
PMID: 19199268BACKGROUNDWu J, Wen JM, Wang YC, Luo WJ, Wang QF, Lv H, Dai B, Ye DW, Su HC, Zhu YP. Prognostic Value of an Immunohistochemical Signature in Patients With Bladder Cancer Undergoing Radical Cystectomy. Front Oncol. 2021 Mar 25;11:641385. doi: 10.3389/fonc.2021.641385. eCollection 2021.
PMID: 33842349BACKGROUNDZheng J, Kong C, Yang X, Cui X, Lin X, Zhang Z. Protein kinase C-alpha (PKCalpha) modulates cell apoptosis by stimulating nuclear translocation of NF-kappa-B p65 in urothelial cell carcinoma of the bladder. BMC Cancer. 2017 Jun 19;17(1):432. doi: 10.1186/s12885-017-3401-7.
PMID: 28629334BACKGROUNDKawano T, Tachibana Y, Inokuchi J, Kang JH, Murata M, Eto M. Identification of Activated Protein Kinase Calpha (PKCalpha) in the Urine of Orthotopic Bladder Cancer Xenograft Model as a Potential Biomarker for the Diagnosis of Bladder Cancer. Int J Mol Sci. 2021 Aug 27;22(17):9276. doi: 10.3390/ijms22179276.
PMID: 34502182BACKGROUNDNetto GJ, Amin MB, Berney DM, Comperat EM, Gill AJ, Hartmann A, Menon S, Raspollini MR, Rubin MA, Srigley JR, Hoon Tan P, Tickoo SK, Tsuzuki T, Turajlic S, Cree I, Moch H. The 2022 World Health Organization Classification of Tumors of the Urinary System and Male Genital Organs-Part B: Prostate and Urinary Tract Tumors. Eur Urol. 2022 Nov;82(5):469-482. doi: 10.1016/j.eururo.2022.07.002. Epub 2022 Aug 11.
PMID: 35965208BACKGROUND
Biospecimen
Urine sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fatma G Sayed, prof
unaffiliation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer at Parasitology department
Study Record Dates
First Submitted
June 19, 2023
First Posted
July 12, 2023
Study Start
October 1, 2023
Primary Completion
June 30, 2025
Study Completion (Estimated)
October 30, 2027
Last Updated
July 12, 2023
Record last verified: 2023-07