Schistosoma Haematobium Clinical Trial
Official title:
Possible Diagnostic Protein Markers in Schistosoma Related Bladder Diseases.
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)
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | October 30, 2027 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years and older |
Eligibility | Inclusion 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. Exclusion Criteria: - patients with concomitant other tumours. - patients with other urinary tract infection. |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University Hospital | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Al-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. — View Citation
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. — View Citation
Chen 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. — View Citation
Efared 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. — View Citation
Eissa 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. — View Citation
El-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. — View Citation
Kawano 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. — View Citation
Nacif-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. — View Citation
Netto 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. — View Citation
Wu 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. — View Citation
Zheng 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NF-kappa-B and Protein kinase Ca | Association and changes of NF-kappa-B and Protein kinase Ca as diagnostic markers in chronic schistosomaiasis with or without bladder cancer | 2 years | |
Primary | heat shock protein | Changes of heat shock protein HSP 70 as urinary biomarkers for Schistosomal bladder diseases. | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03893097 -
Evaluation of Artesunate-mefloquine as a Novel Alternative Treatment for Schistosomiasis in African Children
|
Phase 3 | |
Withdrawn |
NCT02810613 -
Leiden University Medical Center Mini Donor Bank
|
N/A | |
Completed |
NCT00870649 -
Efficacy of Bilhvax in Association With Praziquantel for Prevention of Clinical Recurrences of Schistosoma Haematobium
|
Phase 3 | |
Completed |
NCT00510159 -
Comparing Praziquantel Versus Artesunate + Sulfamethoxypyrazine/Pyrimethamine for Treating Schistosomiasis
|
Phase 2/Phase 3 | |
Completed |
NCT00713999 -
Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar
|
N/A | |
Completed |
NCT01163877 -
Iron Absorption and Utilization in Adolescents Infected With Malaria Parasites, Hookworms or Schistosoma
|
N/A |