- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06901934
JAM3 as a Prognostic Biomarker in Muscle-Invasive Urothelial Carcinoma: Correlation With Therapeutic Response, and Survival Outcomes
JAM3 as a Prognostic Biomarker in Muscle-Invasive Urothelial Carcinoma: Correlation With Therapeutic Response and Survival Outcomes
Bladder cancer(BC) is the 10th most common cancer globally, with a higher incidence in males than females, being the 6th most common cancer in men with high mortality, causing a societal burden worldwide.
Known risk factors include age, gender, cigarettes, genetic factors, and other environmental influences .
BC can be classified into non-muscle-invasive BC (NMIBC) and muscle-invasive BC (MIBC) . MIBC exhibits a more aggressive nature, correlates with a higher level of T-stage, and has more significant genetic heterogeneity .
Despite comprehensive treatment regimens comprising neoadjuvant chemotherapy, radical cystectomy (RC) and adjuvant immunotherapies, a significant proportion of MIBC patients continue to progress to more advanced stages with limited clinical indicators.
Unfortunately, the mechanisms underlying BC initiation, proliferation, and progression remain largely unknown.
The occurrence of genetic alterations is believed to be closely linked to BC tumorigenesis. Therefore, investigating the genetic alterations might offer opportunities to further understand biological changes in BC .
A key mechanism underlying tumor progression and metastasis is the epithelial-mesenchymal transition (EMT), which is associated with increased invasiveness, chemoresistance, and immune evasion.
EMT is characterized by the downregulation of epithelial markers such as E-cadherin (CDH1) and the upregulation of mesenchymal markers like N-cadherin (CDH2), vimentin, Snail, and ZEB proteins .
Emerging evidence suggests that junctional adhesion molecule 3 (JAM3) plays a role in EMT and cancer progression, with documented involvement in gastric cancer.
However, its significance in MIBC remains poorly understood. Investigating JAM3 expression in MIBC may provide novel prognostic insights and help refine patient stratification for NAC and immunotherapy.
Aim:
This study aims to analyze JAM3 expression in transurethral biopsies from MIUC patients and correlate it with:
- Tumor aggressiveness (grading, staging, and histological features).
- Response to neoadjuvant chemotherapy .
- Patient survival and disease progression.
This study will provide a better understanding of JAM3's role in EMT and MIUC progression, offering potential biomarker-driven insights for treatment stratification.
If JAM3 is validated as a prognostic factor, it could guide personalized therapeutic approaches and optimizing NAC outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: zienab yahia
- Phone Number: 20 01060399770
- Email: zienab959@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria
- Patients above 18 years
- Histopathological confirmed TCC
- Patients with MIBC
- Patients eligible for neoadjuvant chemotherapy
Exclusion criteria
- Patients with metastatic disease
- Patients ineligible for systemic therapy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The response to neoadjuvant chemotherapy in muscle invasive bladder cancer in relation to JAM3 expression
Time Frame: from enrollment to the end of treatment at 5 months
|
from enrollment to the end of treatment at 5 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Urologic Neoplasms
- Urinary Bladder Diseases
- Carcinoma
- Urinary Bladder Neoplasms
- Carcinoma, Transitional Cell
Other Study ID Numbers
- JAM3 biomarker bladder cancer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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