Possible Diagnostic Protein Markers in Schistosoma Related Bladder Diseases.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2027-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Circulating Cathodic Antigen Test Compared to Microscopy for Diagnosis of Urinary Schistosomiasis in Sohag

NCT05276414

Urinary Schistosomiases

UNKNOWN

Urinary Schistosomiasis Infection

NCT00138450

Diseases of the Urinary System Schistosomiasis Haematobia

COMPLETED

Evaluation of the Use of a Urin Test Strip to Determine the Spread of Schistosoma Infections in Areas Where Schistosomiasis Infections Are Low in Kenya

NCT00463307

Schistosomiasis Mansoni Circulating Cathodic Antigen Urine Based Dipstick

COMPLETED

Performance of Tests for Schistosoma Haematobium Diagnosis

NCT06808750

Schistosoma Haematobium

COMPLETED

Immunochromatography Versus Microscopy for Diagnosis of Entamoeba Histolytica/Dispar Infection.

NCT04759937

Dysentery Amebic

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Schistosoma Haematobium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Schistosoma haematobium cystitis.

patient has symptoms suggestive of Schistosoma haematobium infection like terminal hematuria and burning micturition