Schistosoma HaematobiumNCT05941884
Possible Diagnostic Protein Markers in Schistosoma Related Bladder Diseases.
An observational study of Schistosoma Haematobium, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schistosoma Haematobium
- What is being tested?
- Immunohistochemistry staining, and microscopic examination of urine
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 30 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- patients with concomitant other tumours.
- patients with other urinary tract infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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)
Read the detailed description
Bleeding, anemia and chronic renal failure are common presentation. Bladder cancer is associated with schistosomiasis, However the mechanism by which it occurs is still controversial. Chronic interaction with the host immune system as well as association with other carcinogenic agents can lead to the neoplastic transformation (3). The International Agency for Research on Cancer classifies the infection with S. haematobium as a group 1 carcinogen, a definitive cause of cancer (5).
Bladder cancer (BC) is the sixth most prevalent cancer in both genders worldwide. Amongst Egyptian males, bladder cancer is the most common malignancy accounting for 16% with more than 7,900 deaths per year. The main risk factor was urinary schistosomiasis which is more frequent in Upper Egypt (1).
Urothelial carcinoma represents the most common histologic type of BC, accounting for 90% of all cases. Squamous cell carcinoma may develop following bilharziasis infection, in addition other types includes adenocarcinoma and small cell carcinoma were reported (6). The WHO classification includes urothelial papilla, papillary urothelial neoplasm of low malignant potential (PUNLMP), low-grade urothelial carcinoma (LGPUC) and high- grade UC (HGPUC) (7).
Urine cytology is the only established noninvasive adjunct to cystoscopy. Being in close contact with tumor cells and adjacent inflamed urothelium. Thus, immune mediators in urine may serve as biomarkers (8). Urine biomarkers of schistosomal bladder cancer can be used as diagnostic markers in patients, and prognostic indicators of disease survival, and as early detectors of recurrent disease in the monitored patient (9).
Heat shock proteins (HSPs) are synthesized by cells in response to various stress conditions, including carcinogenesis. These molecules have been studied in several malignancies, they may be useful markers for patients with schistosomiasis-associated bladder cancer and may be used for predicting disease progression. (10). HSPs are upregulated when cells are exposed to elevated temperature. In neoplasia, the expression of HSPs is implicated in the regulation of apoptosis and tumor-cell growth, helps tumor to evade immune surveillance. As it has been reported to abort Th1 effector immunity and enhance Th2 down- regulatory immune responses. Thus, downregulate antitumor effector T cells (8). Urine proteome profile provide deeper insights into urogenital schistosomiasis, it's carcinogenesis and highlight potential biomarkers for diagnosis and/or prognosis (11).
Immunohistochemistry (IHC) is currently the most widely used pathological technique for accurate diagnosis of urinary bladder neoplasms. Moreover, identification and validation of the prognostic IHC signature have been reported in various cancer types and proved to be a promising complement in therapeutic planning and patient management (12). As oxidative stress and immune defense systems responsible for microbicide activity are the most representative clusters in urogenital schistosomiasis patients. Proteins involved in immunity, negative regulation of endopeptidase activity, and inflammation were more prevalent in UGS patients with bladder cancer (11).
NF-ƙB was first identified in active B cells by its binding affinity to immunoglobulin enhancer. NF-ƙB serves as dominant modulator of immuno-inflammatory responses. (13). It plays a critical role in normal physiology and bladder cancer progression. NF-ƙB orchestrates protein interactions (PTEN, survivin, VEGF), regulation (CYLD, USP13) and gene expression (Trp 53) resulting in bladder cancer progression, recurrence, and resistance to therapy. Bladder cancer patients have constitutively active NF-ƙB triggered by pro-inflammatory cytokines, chemokines, and hypoxia, augmenting carcinogenesis and progression (14).
Further, Protein kinase C α (PKC) is one of the serine/threonine kinases that regulates a variety of cellular biological process, such as apoptosis. It has been firmly established that PKCs are closely related to process of tumorigenesis, including the initiation and progression of bladder cancer (15). In addition, activated PKC α is involved in bladder cancer cell proliferation, survival, invasion, migration, and anticancer drug resistance (16).
In literature, the evaluation of schistosomal infestation is not precise as it depends on the histopathologic findings, which proved to be less accurate. Most of them focused on the prognostic role of biomarkers rather than their role in diagnosis and pathogenesis.
Our aim in this study is to identify the potential causal relationship between schistosomal infection and levels of NF-kappa-B and Protein kinase C α signaling and bladder cancer development and highlights their role in bladder cancer pathogenesis
- Conditions
- Schistosoma Haematobium
- Being tested
- Immunohistochemistry staining,, microscopic examination of urine
- Medical subject headings
- Schistosomiasis haematobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemistry staining,Diagnostic test
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.
microscopic examination of urineDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Schistosoma haematobium cystitis. | patient has symptoms suggestive of Schistosoma haematobium infection like terminal hematuria and burning micturition Receives: Diagnostic Test: microscopic examination of urine | |
| Healthy personnel. | as control group Receives: Diagnostic Test: microscopic examination of urine | |
| Schistosomal bladder cancer. | from patient undergone diagnostic cystoscopy and sampling and confirmed pathologically as Schistosomal bladder cancer. Receives: Diagnostic Test: Immunohistochemistry staining,; Diagnostic Test: microscopic examination of urine | |
| non Schistosomal bladder cancer. | from patient undergone diagnostic cystoscopy and sampling and confirmed pathologically as non Schistosomal bladder cancer. Receives: Diagnostic Test: Immunohistochemistry staining, | |
| Schistosomal cystitis patients. | from patient undergone diagnostic cystoscopy and sampling and confirmed pathologically as Schistosomal cystitis Receives: Diagnostic Test: Immunohistochemistry staining, | |
| healthy bladder tissue from tissue biopsy patient with benign prostatic hyperplasia. | as control group Receives: Diagnostic Test: Immunohistochemistry staining, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
heat shock protein
Changes of heat shock protein HSP 70 as urinary biomarkers for Schistosomal bladder diseases.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Schistosoma HaematobiumStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Mohammad Hussein, Assiut University
- Investigators
- Fatma G Sayed, prof, Study director, unaffiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941884
- Sponsor's protocol ID
- PDPMSRBD
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32165946Efared 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.
PubMed 35164874Nacif-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.
PubMed 31341177Al-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.
PubMed 36204357Chen 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.
PubMed 23082147Eissa 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.
PubMed 26105083El-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.
PubMed 19199268Wu 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.
PubMed 33842349Zheng 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.
PubMed 28629334Kawano 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.
PubMed 34502182Netto 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.
PubMed 35965208
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Diagnostic Protein Markers in Schistosoma Related Bladder Diseases.
- ClinicalTrials.gov ID
- NCT05941884
- Acronym / sponsor ID
- PDPMSRBD
- Conditions
- Schistosoma Haematobium
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Bleeding, anemia and chronic renal failure are common presentation. Bladder cancer is associated with schistosomiasis, However the mechanism by which it occurs is still controversial. Chronic interaction with the host immune system as well as association with other carcinogenic agents can lead to the neoplastic transformation (3). The International Agency for Research on Cancer classifies the infection with S. haematobium as a group 1 carcinogen, a definitive cause of cancer (5).
Bladder cancer (BC) is the sixth most prevalent cancer in both genders worldwide. Amongst Egyptian males, bladder cancer is the most common malignancy accounting for 16% with more than 7,900 deaths per year. The main risk factor was urinary schistosomiasis which is more frequent in Upper Egypt (1).
Urothelial carcinoma represents the most common histologic type of BC, accounting for 90% of all cases. Squamous cell carcinoma may develop following bilharziasis infection, in addition other types includes adenocarcinoma and small cell carcinoma were reported (6). The WHO classification includes urothelial papilla, papillary urothelial neoplasm of low malignant potential (PUNLMP), low-grade urothelial carcinoma (LGPUC) and high- grade UC (HGPUC) (7).
Urine cytology is the only established noninvasive adjunct to cystoscopy. Being in close contact with tumor cells and adjacent inflamed urothelium. Thus, immune mediators in urine may serve as biomarkers (8). Urine biomarkers of schistosomal bladder cancer can be used as diagnostic markers in patients, and prognostic indicators of disease survival, and as early detectors of recurrent disease in the monitored patient (9).
Heat shock proteins (HSPs) are synthesized by cells in response to various stress conditions, including carcinogenesis. These molecules have been studied in several malignancies, they may be useful markers for patients with schistosomiasis-associated bladder cancer and may be used for predicting disease progression. (10). HSPs are upregulated when cells are exposed to elevated temperature. In neoplasia, the expression of HSPs is implicated in the regulation of apoptosis and tumor-cell growth, helps tumor to evade immune surveillance. As it has been reported to abort Th1 effector immunity and enhance Th2 down- regulatory immune responses. Thus, downregulate antitumor effector T cells (8). Urine proteome profile provide deeper insights into urogenital schistosomiasis, it's carcinogenesis and highlight potential biomarkers for diagnosis and/or prognosis (11).
Immunohistochemistry (IHC) is currently the most widely used pathological technique for accurate diagnosis of urinary bladder neoplasms. Moreover, identification and validation of the prognostic IHC signature have been reported in various cancer types and proved to be a promising complement in therapeutic planning and patient management (12). As oxidative stress and immune defense systems responsible for microbicide activity are the most representative clusters in urogenital schistosomiasis patients. Proteins involved in immunity, negative regulation of endopeptidase activity, and inflammation were more prevalent in UGS patients with bladder cancer (11).
NF-ƙB was first identified in active B cells by its binding affinity to immunoglobulin enhancer. NF-ƙB serves as dominant modulator of immuno-inflammatory responses. (13). It plays a critical role in normal physiology and bladder cancer progression. NF-ƙB orchestrates protein interactions (PTEN, survivin, VEGF), regulation (CYLD, USP13) and gene expression (Trp 53) resulting in bladder cancer progression, recurrence, and resistance to therapy. Bladder cancer patients have constitutively active NF-ƙB triggered by pro-inflammatory cytokines, chemokines, and hypoxia, augmenting carcinogenesis and progression (14).
Further, Protein kinase C α (PKC) is one of the serine/threonine kinases that regulates a variety of cellular biological process, such as apoptosis. It has been firmly established that PKCs are closely related to process of tumorigenesis, including the initiation and progression of bladder cancer (15). In addition, activated PKC α is involved in bladder cancer cell proliferation, survival, invasion, migration, and anticancer drug resistance (16).
In literature, the evaluation of schistosomal infestation is not precise as it depends on the histopathologic findings, which proved to be less accurate. Most of them focused on the prognostic role of biomarkers rather than their role in diagnosis and pathogenesis.
Our aim in this study is to identify the potential causal relationship between schistosomal infection and levels of NF-kappa-B and Protein kinase C α signaling and bladder cancer development and highlights their role in bladder cancer pathogenesis
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Schistosoma haematobium cystitis. | – | Diagnostic Test: microscopic examination of urinepatient has symptoms suggestive of Schistosoma haematobium infection like terminal hematuria and burning micturition |
| Healthy personnel. | – | Diagnostic Test: microscopic examination of urineas control group |
| Schistosomal bladder cancer. | – | Diagnostic Test: Immunohistochemistry staining,, Diagnostic Test: microscopic examination of urinefrom patient undergone diagnostic cystoscopy and sampling and confirmed pathologically as Schistosomal bladder cancer. |
| non Schistosomal bladder cancer. | – | Diagnostic Test: Immunohistochemistry staining,from patient undergone diagnostic cystoscopy and sampling and confirmed pathologically as non Schistosomal bladder cancer. |
| Schistosomal cystitis patients. | – | Diagnostic Test: Immunohistochemistry staining,from patient undergone diagnostic cystoscopy and sampling and confirmed pathologically as Schistosomal cystitis |
| healthy bladder tissue from tissue biopsy patient with benign prostatic hyperplasia. | – | Diagnostic Test: Immunohistochemistry staining,as control group |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- patients with concomitant other tumours.
- patients with other urinary tract infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunohistochemistry staining,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. | Diagnostic test | Schistosomal bladder cancer., Schistosomal cystitis patients., healthy bladder tissue from tissue biopsy patient with benign prostatic hyperplasia., non Schistosomal bladder cancer. |
| microscopic examination of urineUrine 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. | Diagnostic test | Healthy personnel., Schistosoma haematobium cystitis., Schistosomal bladder cancer. |
Primary outcome
NF-kappa-B and Protein kinase Cα
Time frame: 2 years
Association and changes of NF-kappa-B and Protein kinase Cα as diagnostic markers in chronic schistosomaiasis with or without bladder cancer
heat shock protein
Time frame: 1 year
Changes of heat shock protein HSP 70 as urinary biomarkers for Schistosomal bladder diseases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Background: PubMed 32165946Amin 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.
- Background: PubMed 35164874Efared 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.
- Background: PubMed 31341177Nacif-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.
- Background: PubMed 36204357Al-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.
- Background: PubMed 23082147Chen 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.
- Background: PubMed 26105083Eissa 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.
- Background: PubMed 19199268El-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.
- Background: PubMed 33842349Wu 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.
- Background: PubMed 28629334Zheng 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.
- Background: PubMed 34502182Kawano 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.
- Background: PubMed 35965208Netto 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatma G Sayed, prof study director
unaffiliation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schistosoma Haematobium, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact samah M Hussein, Assist Lect (00201025180292, samahahmad0411@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NF-kappa-B and Protein kinase Cα (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05941884, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.