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Not yet recruitingNCT06901934Updated Mar 30, 2025

JAM3 as a Prognostic Biomarker in Muscle-Invasive Urothelial Carcinoma: Correlation With Therapeutic Response, and Survival Outcomes

An observational study in Urothelial Carcinoma Bladder, sponsored by Zeinab Yahia Zaki. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by Zeinab Yahia Zaki · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
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Study 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 .

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.

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Conditions studied

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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 40 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

This is the only study on the registry with Zeinab Yahia Zaki as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

:Patients diagnosed with muscle invasive urothelial carcinoma( MIUC) and eligible for neoadjuvant chemotherapy( NAC)

Inclusion criteria

  1. Patients above 18 years
  2. Histopathological confirmed TCC
  3. Patients with MIBC
  4. Patients eligible for neoadjuvant chemotherapy

Exclusion criteria

Exclusion criteria

  1. Patients with metastatic disease
  2. Patients ineligible for systemic therapy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • Otherjunctional 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)..

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What researchers measure

Primary outcomes

  1. 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

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Study locations

No study locations are listed for this record.

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References and documents

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. Erratum In: Cancer Lett. 2025 Apr 28;616:217592. doi: 10.1016/j.canlet.2025.217592. PubMed 39586489 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06901934
Lead sponsor
Zeinab Yahia Zaki
Responsible party
Zeinab Yahia Zaki (zeinab yahia zaki, Assiut University) — Sponsor-investigator
First posted
Mar 30, 2025
Start date
Oct 1, 2025 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2028 (estimated)
Last update
Mar 30, 2025

Study contacts

zienab yahia
Contact
zienab959@gmail.com
20 01060399770

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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