Urothelial Carcinoma BladderNCT06901934
JAM3 as a Prognostic Biomarker in Muscle-Invasive Urothelial Carcinoma: Correlation With Therapeutic Response, and Survival Outcomes
An observational study of Urothelial Carcinoma Bladder, run by Zeinab Yahia Zaki.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma Bladder
- What is being tested?
- junctional adhesion molecule3 expression by immunhistochemistry
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2028
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: :Patients diagnosed with muscle invasive urothelial carcinoma( MIUC) and eligible for neoadjuvant chemotherapy( NAC)
Who may be able to join
- Patients above 18 years
- Histopathological confirmed TCC
- Patients with MIBC
- Patients eligible for neoadjuvant chemotherapy
Who cannot join
- Patients with metastatic disease
- Patients ineligible for systemic therapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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 .
Read more
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.
- Conditions
- Urothelial Carcinoma Bladder
- Being tested
- junctional adhesion molecule3 expression by immunhistochemistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
junctional adhesion molecule3 expression by immunhistochemistryOther
- Data record of patient will be reviewed for the following:
- Clinical features:
- Age
- Performance status
- Risk factors(smoking,stones or bilharziasis)
- Comorbidities
- Family history
- Pathological features:
- Histological subtype
- Grade
- Muscle invasion
- Carcinoma in situ
- Immunohistochemistry(IHC):
JAM3 expression by IHC
- TNM staging
- Number of chemotherapy cycles received
- Radical surgery or
- CCRT and type of concurrent
- Post treatment histological response
- . Follow-Up and Survival Analysis:
- During treatment: Monitoring for adverse events of chemotherapy and clinical response.
- After treatment: Imaging and clinical examination every 3 months for 2 years.
- Correlation of JAM3 expression with progression-free survival (PFS) and overall survival (OS)..
What is being measured
The primary outcome is the main question the study is designed to answer.
The response to neoadjuvant chemotherapy in muscle invasive bladder cancer in relation to JAM3 expression
Measured: from enrollment to the end of treatment at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial Carcinoma BladderStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Zeinab Yahia Zaki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeinab Yahia Zaki, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901934
- Sponsor's protocol ID
- JAM3 biomarker bladder cancer
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Steiner L, Eldh M, Offens A, Veerman RE, Johansson M, Hemdan T, Netterling H, Huge Y, Abdul-Sattar Aljabery F, Alamdari F, Liden O, Sherif A, Gabrielsson S. Protein profile in urinary extracellular vesicles is a marker of malignancy and correlates with muscle invasiveness in urinary bladder cancer. Cancer Lett. 2025 Jan 28;609:217352. doi: 10.1016/j.canlet.2024.217352. Epub 2024 Nov 23.
PubMed 39586489
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JAM3 as a Prognostic Biomarker in Muscle-Invasive Urothelial Carcinoma: Correlation With Therapeutic Response and Survival Outcomes
- ClinicalTrials.gov ID
- NCT06901934
- Acronym / sponsor ID
- JAM3 biomarker bladder cancer
- Conditions
- Urothelial Carcinoma Bladder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zeinab Yahia ZakiUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 30 Mar 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- :Patients diagnosed with muscle invasive urothelial carcinoma( MIUC) and eligible for neoadjuvant chemotherapy( NAC)
Key inclusion criteria (4 listed)
- Patients above 18 years
- Histopathological confirmed TCC
- Patients with MIBC
- Patients eligible for neoadjuvant chemotherapy
Key exclusion criteria (2 listed)
- Patients with metastatic disease
- Patients ineligible for systemic therapy
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 |
|---|---|---|
| junctional adhesion molecule3 expression by immunhistochemistry* Data record of patient will be reviewed for the following: * Clinical features: * Age * Performance status * Risk factors(smoking,stones or bilharziasis) * Comorbidities * Family history * Pathological features: * Histological subtype * Grade * Muscle invasion * Carcinoma in situ * Immunohistochemistry(IHC): JAM3 expression by IHC * TNM staging * Number of chemotherapy cycles received * Radical surgery or * CCRT and type of concurrent * Post treatment histological response * . Follow-Up and Survival Analysis: * During treatment: Monitoring for adverse events of chemotherapy and clinical response. * After treatment: Imaging and clinical examination every 3 months for 2 years. * Correlation of JAM3 expression with progression-free survival (PFS) and overall survival (OS).. | Other | – |
Primary outcome
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
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 30 Mar 2025.
- Background: PubMed 39586489Steiner L, Eldh M, Offens A, Veerman RE, Johansson M, Hemdan T, Netterling H, Huge Y, Abdul-Sattar Aljabery F, Alamdari F, Liden O, Sherif A, Gabrielsson S. Protein profile in urinary extracellular vesicles is a marker of malignancy and correlates with muscle invasiveness in urinary bladder cancer. Cancer Lett. 2025 Jan 28;609:217352. doi: 10.1016/j.canlet.2024.217352. Epub 2024 Nov 23.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma Bladder, run by Zeinab Yahia Zaki.
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 4 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 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 zienab yahia (20 01060399770, zienab959@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT06901934, which also lists 1 linked publication.
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 30 Mar 2025.