NCT06325423Not yet recruiting
Predicting Response to Neoadjuvant Chemotherapy in Muscle-invasive Bladder Cancer
The Impact of Tumor Microenvironment and Clinicopathological Features in Predicting Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer
Source: ClinicalTrials.gov · Last updated 26 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Bladder cancer (BC) is the 10th most commonly diagnosed cancer worldwide and the second most common cancer among Egyptian males. The mainstay of treatment of muscle-invasive BC( MIBC) is neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) or bladder preservation(BP) using maximal transurethral resection of the bladder tumor followed by chemoradiation. The rationale to use NAC before RC or BP is to eradicate micro-metastasis and to downstage the primary tumor. The 5-year cancer-specific survival for responders to NAC is 90%, in contrast to 30-40% for those not obtaining an objective response. Drawbacks of NAC are disappointing delay of surgery in non-responders and the potential toxicity. So, predictors of response to NAC are necessary to identify patients who may achieve pathologic complete response and will benefit from BP, and the others who may not respond to NAC and spare them NAC toxicity and RC delay. Tumor microenvironment (TME), including neutrophil extracellular traps (NETs), and CD8+ T lymphocytes is a promising predictor of response to NAC in MIBC. NETs are reticulated DNA structures decorated with various protein substances (e.g., histones, myeloperoxidase, neutrophil elastase).NETs are involved in tumor growth, metastasis, and treatment resistance. Moreover, NETs can inhibit T cell responses, thereby promoting tumor growth. On the other hand, immune cells that are present in the TME play a major role in slowing down tumor progression. CD8+T lymphocytes play a central role in immune-mediated control of cancer . Also, they have been found to be a prognostic tool for advanced BC.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 16 Mar 2024
- Start date
- Apr 2024
- Primary completion date
- Jun 2025
- Lead sponsor
- Assiut University
- Diseases
- Bladder cancer
- NCT number
- NCT06325423
What you commit to
- Study type: Observational
- Planned participants: 50
- From Apr 2024 to the primary completion date, Jun 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Metastatic bladder cancer.
Other
- Non urothelial carcinoma.
- Not muscle invasive \< T2.
- No available paraffin-embedded TUR specimens for IHC.
Who the study is looking for
- Pathologically proven pure urothelial carcinoma, or morphologic variant of urothelial carcinoma.
- Patients with ≥T2, N0-1, M0, according to American Joint Committee on Cancer (AJCC) TNM Staging System for Bladder Cancer 8th ed., 2017.
- Patients who received platinum-based neoadjuvant chemotherapy before RC or BP.
- Available paraffin-embedded TUR specimens for Immunohistochemistry (IHC).
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.