NCT06358599Completed
The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Bladder Cancer Who Underwent Radical Cystectomy
The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Who Underwent Radical Cystectomy: A Multicenter Study of the Turkish Urooncology Association
Source: ClinicalTrials.gov · Last updated 10 Apr 2024
Brief summary (registry, in English)
The World Health Organization 2016 bladder tumor classification reported that the diagnosis of variant histology has increased from 6% to 33% in the last 2 decades, and there is an increasing interest in investigating the effects on disease management, treatment options, and survival outcomes in bladder tumors with variant histology. In bladder tumors, variant histology is known to be more aggressive and has a worse prognosis than pure urothelial cancer, and most cases are muscle invasive at diagnosis. Neoadjuvant cisplatin-containing combination chemotherapy is known to improves overall survival in patients with urothelial cancers. However, it is unclear whether patients with non-pure urothelial cancer (variant) histology will also benefit from neoadjuvant chemotherapy. The investigators aimed to evaluate the role of Neoadjuvant cisplatin-containing combination chemotherapy in the final treatment plan and its impact on survival in patients with bladder cancer who were diagnosed with variant histology in the radical cystectomy specimen.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 221 (actual)
- First submitted
- 13 Mar 2024
- Start date
- 7 Jan 2021
- Primary completion date
- 20 Oct 2023
- Lead sponsor
- Ankara Etlik City Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT06358599
What you commit to
- Study type: Observational
- Participants enrolled: 221
- From 7 Jan 2021 to the primary completion date, 20 Oct 2023
- 1 site in 1 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.
Prior treatment
- Although RC histopathology was variant histology, patients in whom variant histology was not detected in previously transurethral resection bladder pathology
- Patients who received therapies other than radical cystectomy (intravesical bacillus-calmette-guerin or chemotherapy) were excluded from the study.
- Patients with a concomitant diagnosis of upper urinary tract urothelial carcinoma
Other
- Patients with histopathologically pure urothelial carcinoma
Who the study is looking for
- Patients with squamous cell, micropapillary, nested variant, sarcomatoid, neuroendocrine, or plasmacytoid variant histology
- Patients who were non-metastatic at diagnosis
- Patients who completed staging and demographic data,
- Patients with pathological stage (p)T2 or high grade pT1, clinical stage (c)N0 or cN1, and underwent radical cystectomy
Age in the registry: 45 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ankara Etlik City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.