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Bladder Cancer clinical trials

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NCT ID: NCT02675829 Recruiting - Lung Cancer Clinical Trials

Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers

Start date: February 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out what effects, a drug called ado-trastuzumab emtansine has on the patient and their cancer which is thought to be controlled by the abnormal HER2 gene.

NCT ID: NCT02665039 Completed - Bladder Cancer Clinical Trials

A Trial With Vinflunine in Patients With Metastatic Bladder Cancer and Impaired Renal Function

VINGEM
Start date: April 2014
Phase: Phase 2
Study type: Interventional

This study aim to compare the efficacy, safety and quality of life of vinflunine/gemcitabine and carboplatin/gemcitabine in patients with metastatic urothelial cancer and impaired renal function.

NCT ID: NCT02662309 Active, not recruiting - Bladder Cancer Clinical Trials

Preoperative MPDL3280A in Transitional Cell Carcinoma of the Bladder

ABACUS
Start date: February 2016
Phase: Phase 2
Study type: Interventional

ABACUS is an open-label, international, multi-centre, window of opportunity phase II trial for patients with histologically confirmed (T2-T4a) transitional cell carcinoma of the bladder. The trial aims to test the efficacy of preoperative MPDL3280A and will include extensive biomarker work on samples from these patients. Eligible patients will receive two 3-weekly cycles of MPDL3280A pre-cystectomy. Following cystectomy, patients will be followed up for safety, survival, and disease data.

NCT ID: NCT02662166 Completed - Bladder Cancer Clinical Trials

MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer

MIB
Start date: July 2014
Phase: N/A
Study type: Interventional

Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.

NCT ID: NCT02662062 Active, not recruiting - Bladder Cancer Clinical Trials

Pembrolizumab With Chemoradiotherapy as Treatment for Muscle Invasive Bladder Cancer

PCR-MIB
Start date: August 2016
Phase: Phase 2
Study type: Interventional

This study will enrol patients with maximally resected (via transurethral resection (TURBT) non-metastatic muscle invasive bladder cancer, who either wish to attempt bladder preservation therapy or are ineligible for cystectomy. Patients must have adequate organ function and performance status to receive cisplatin based chemoradiotherapy, and no contraindications to the use of pembrolizumab. The study will enrol 30 patients to be treated with pembrolizumab and radiotherapy. All patients will be planned to be treated with 64Gy of radiation therapy in 32 fractions over 6 weeks and 2 days. All patients will receive cisplatin 35mg/m2 IV concurrently weekly with radiation therapy for 6 doses total. Pembrolizumab will commence concurrently with radiation and be given 200mg IV every 21 days, continuing until the 12 week cystoscopy and assessment. Surveillance cystoscopy will be performed 12 weeks after the commencement of chemoradiotherapy, and assess the rate of complete response to therapy. A safety follow up visit will occur 4 and 12 weeks post cystoscopy. From week 31 survival follow up will commence with clinical assessment, cystoscopy and CT staging performed at intervals until 5 years. The objective of the study is to assess the safety and feasibility of combining pembrolizumab with chemoradiotherapy. The primary endpoint assessed will be safety, as defined by a satisfactorily low rate of unacceptable toxicity (G3-4 adverse events or failure of completion of planned chemotherapy and radiotherapy according to defined parameters). The secondary endpoint will be efficacy, as assessed by complete response rate of the primary tumour at first post chemoradiotherapy cystoscopic assessment. Exploratory analysis will include assessment of tumour histopathological, molecular, genetic and immunological parameters. It is expected that it will take two years to accrue the required 30 patients.

NCT ID: NCT02660645 Recruiting - Bladder Cancer Clinical Trials

Blue Light Cystoscopy With Cysview® Registry

BLCCR
Start date: April 2014
Phase:
Study type: Observational [Patient Registry]

Registry study to gather more information on the current use of Blue Light Cystoscopy with Cysview (BLCC) in urologists' practices.

NCT ID: NCT02660190 Completed - Bladder Cancer Clinical Trials

Photodynamic Diagnosis (PDD) in Flexible Cystoscopy

DaBlaCa-11
Start date: February 2016
Phase: Phase 3
Study type: Interventional

Photodynamic diagnostic (PDD) is a technique where a photodynamic drug is installed preoperatively in the bladder. Mucosa cells with a higher metabolism than normal urothelial cells, e.g. cancer cells, absorbs this drug which is utilized during cystoscopy where blue light is absorbed by the drug, making the surgeon able to distinguish tumor cells from normal cells and thus being able to identify flat lesions and small papillomas missed in white light cystoscopy. The use of PDD at this primary transurethral resection of bladder tumour (TURB) has been shown to be associated with a lower recurrence rate within the first year, probably mostly owing to a higher detection rate of small papillomas and dysplasia that therefore can be relevantly treated at an early stage. Despite the use of PDD at the primary TURB, a high number of patients experience an early recurrence and patients with carcinoma in situ (CIS) treated with bacillus Calmette-Guerin (BCG) may have recurrence of their CIS or recurrence of papillomas despite the peroperative use of PDD. Whereas the use of PDD is well established in the TURB setting, the use of PDD in the follow-up setting with flexible cystoscopy in the outpatient clinic is not investigated. Feasibility studies have been successful but the clinical relevance and benefits have not been investigated so far. Thesis The thesis of the study is that the use of PDD in the outpatient clinic in patients with a high recurrence risk undergoing follow-up flexible cystoscopy will result in diagnosis of papillomas earlier than by the use of conventional flexible cystoscopy in white light. Thus, a higher number of tumours can be treated in the outpatient setting without the need for procedures in general anesthesia. Furthermore, the number of follow-up cystoscopies can be reduced if PDD is used at the first cystoscopy following TURB. Aims To investigate whether the use of PDD when performing a flexible cystoscopy in the outpatient clinic can reduce the number of recurrences of large size papillomas that cannot be treated by simple fulguration without general anesthesia. Furthermore, to investigate whether the use of PDD in follow-up cystoscopy in patients with earlier complete response to BCG on CIS, can increase the detection rate of CIS recurrences.

NCT ID: NCT02657486 Active, not recruiting - Bladder Cancer Clinical Trials

BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder

Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to study the activity and effects of BGJ398 on bladder cancer tumors that are confined to the lining of the bladder.

NCT ID: NCT02655081 Completed - Bladder Cancer Clinical Trials

Investigating the Use of a Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy

IMPACT
Start date: July 2015
Phase: Phase 2
Study type: Interventional

To provide patients with bladder cancer who are scheduled to undergo radical cystectomy with a preoperative high-arginine nutritional supplement. The investigator will measure patient adherence to the regimen, tolerability of the supplement and feasibility of supplementation. Secondary outcome measures will include differences in length of stay and complication rate between groups.

NCT ID: NCT02648178 Completed - Lung Cancer Clinical Trials

Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers

Start date: June 2016
Phase: N/A
Study type: Interventional

This study will test feasibility, in smokers with lung, head & neck, and bladder cancers, that examines the effect of e-cigarette substitution, on measures of smoking-related toxicity and medical outcomes. The aim of the study is to determine the appeal of e-cigarettes compared to regular combustible cigarettes.