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Urinary Bladder Neoplasms clinical trials

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NCT ID: NCT02788201 Completed - Bladder Cancer Clinical Trials

Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma

Start date: March 27, 2017
Phase: Phase 2
Study type: Interventional

Background: Advanced urothelial cancer has no cure. But only a few chemotherapy drugs have been tested for it. The Co-eXpression ExtrapolatioN (COXEN) model predicts if cells respond to treatment. It may also help determine which drugs fight urothelial cancer based on the characteristics of a tumor. Researchers want to test if this model can choose the best therapy for advanced urothelial cancer within 3 weeks and how tumors respond to the next best therapy. Objective: To test if the COXEN model can choose the best therapy for advanced urothelial cancer within 3 weeks. Eligibility: People ages 18 and older whose urothelial cancer has spread after at least 1 line of chemotherapy Design: Participants will be screened with medical history, physical exam, blood and urine tests, and tumor scans. Participants will provide a tumor sample from a previous surgery and a new biopsy. A needle will remove a small piece of tumor. Participants will repeat screening tests, plus have an electrocardiogram (EKG) and scan. For the scan, they will get an injection of radioactive drug. They will lie in a machine that takes pictures. Participants will take the drugs assigned by the COXEN model. They will have visits every 2-3 weeks. These will include blood and urine tests. Participants will have tumor scans every 8-9 weeks. Participants may have another biopsy. Participants will take the drugs until they can't tolerate the side effects or their cancer worsens. They may be assigned to a second COXEN therapy. Participants will have a follow-up visit 4-5 weeks after their last drug dose. Participants will be contacted by phone every few months until death.

NCT ID: NCT02785887 Completed - Breast Cancer Clinical Trials

Impact of Geriatrician Interventions on Chemotherapy Delivery in Vulnerable Elderly Oncology Patients

GIVE
Start date: August 1, 2014
Phase: N/A
Study type: Interventional

This is a randomized parallel group trial designed to evaluate the impact of implementing geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA), on the ability to deliver adequate chemotherapy treatment, as measured by relative dose intensity (RDI).

NCT ID: NCT02781428 Completed - Bladder Cancer Clinical Trials

To Detect the Sensitivity of the UroMark Assay

DETECT II
Start date: September 26, 2016
Phase:
Study type: Observational

This is a prospective multicentre observational study to assess the sensitivity of the UroMark assay to detect bladder cancer in participants with new or recurrent disease. The study will recruit patients with newly detected or recurrent bladder cancer. The reference standard will be histopathological confirmation of tumour stage and (Ta, T1, ≥T2) and grade 1, 2 or 3 diseases with or without CIS, or CIS alone. Patients with a visual diagnosis of bladder cancer following cystoscopy will be approached and asked to consent for this study. Consenting participants will be provided with a urine sample collection kit and asked to provide a urine sample. Samples can be provided at home and posted to the receiving lab using the stamped addressed envelope. The urine sample must be obtained before TURBT and following TURBT, patients with NMIBC who require surveillance cystoscopy will be asked to provide a urine sample at 3 monthly intervals for up to 2 years. The study will be conducted in at least 11 NHS trusts. As DETECT II is an observation study requiring provision of a urine sample, it will be possible for patients in DETECT II to be recruited to other trials.

NCT ID: NCT02778243 Completed - Clinical trials for Urinary Bladder Neoplasms

Sexual Steroids: Relationship Between Serum and Prostatic Tissue Level

STERPROSER
Start date: September 2014
Phase: N/A
Study type: Interventional

Patients followed in the Foch Hospital Urology Department (Suresnes): Patients justifying a prostatectomy. - Patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer). - Patients with benign prostate hyperplasia who justified a prostatectomy. Compare serum sexual steroid concentrations and intra-tissue on healthy prostates and prostate adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate specific blood sample under study (30mL) will be performed preoperatively in Patients followed in Foch Hospital Urology Department (Suresnes), and a Removal of a fragment of prostate tissue or metastasis will be analyze. Aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy prostates and prostate adenomas compared to concentrations measured in patients operated for prostate cancer.

NCT ID: NCT02773849 Completed - Clinical trials for Superficial Bladder Cancer

ADSTILADRIN (=INSTILADRIN) in Patients With High Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

Start date: September 19, 2016
Phase: Phase 3
Study type: Interventional

Previous multi-dose Phase I and Phase II clinical studies have demonstrated that ADSTILADRIN is a safe and effective treatment for BCG-refractory and recurrent NMIBC. This Phase III study is designed to expand those observations using a high dose of ADSTILADRIN in patients that are "BCG Unresponsive" which refers to patients with high-grade NMIBC who are unlikely to benefit from and should not receive further intravesical BCG.

NCT ID: NCT02756637 Completed - Bladder Cancer Clinical Trials

Neutrophil-to-Lymphocyte Ratio in Bladder Cancer: A Secondary Biomarker Analysis of SWOG 8710

Start date: April 2016
Phase:
Study type: Observational

The purpose of this study is to perform a secondary analysis of SWOG 8710 to assess NLRs value as a biomarker. Specifically, the investigators test two hypotheses: 1) that baseline NLR is correlated with overall survival after curative treatment for BC and 2) that baseline NLR is correlated with the survival benefit of NAC. The study will look at the data from participants of the SWOG 8710 study.

NCT ID: NCT02753309 Completed - Bladder Cancer Clinical Trials

A Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer

Start date: June 2016
Phase: Early Phase 1
Study type: Interventional

This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG.

NCT ID: NCT02748200 Completed - Toxicity Clinical Trials

External Beam Radiotherapy for Muscle Invasive Bladder Cancer

Start date: August 2014
Phase: Phase 1
Study type: Interventional

In this phase 1 trial, the investigators will prospectively evaluate 3 different external beam radiotherapy (EBRT) schedules. In every schedule, the whole bladder will be treated to 40 Gray (Gy) in 20 fractions, 5 fractions/week, 4 weeks in total. Based on the summation of abnormalities seen on pre- (initial tumor region) and post transurethral resection zone of fibrosis Diffusion weighted-magnetic resonance imaging (MRI) images the tumor region is delineated and defined as a gross tumor volume (GTV). The GTV will be treated using a simultaneous integrated boost (SIB): without extending the 4-weeks treatment period, 3 different dose levels will be implemented in order to increase the biological equivalent dose (BED), as muscle invasive bladder cancer has been shown to be dose-sensitive.

NCT ID: NCT02745301 Completed - Clinical trials for Bladder Cancer, Biomarkers

Urinary Biomarkers in the Detection of Urothelial Carcinoma of the Bladder

Start date: April 2016
Phase:
Study type: Observational

To assess the persistence of bladder cancer-specific biomarkers in urine collected pre-operatively, in resected cancer tissue, and in urine collected post-operatively. A panel of sensitive and specific bladder cancer biomarkers will be used to establish a signature of disease in pre-operative patients with a positive diagnosis for bladder cancer by current standard of care (e.g., in-office cystoscopy, OR cystoscopy). The specificity of these markers will be assessed, as well as the degree of non-specific signal attributable to other sources of biomolecules, by analyzing resected tumor tissue for the same biomarkers. Finally, post-operative urine will be assessed for the presence of these markers. To the extent this biomarker panel can be determined to be specific and sensitive, it may serve as an indicator of the degree to which the surgical intervention successfully eradicated the underlying disease. The investigators also aim to assess the stability of a biomarker signature in urine but evaluating several patient specimens over various time points throughout the day.

NCT ID: NCT02738827 Completed - Bladder Cancer Clinical Trials

Diode Laser Treatment of Bladder Tumors

Start date: November 2015
Phase: N/A
Study type: Interventional

Laser treatment of pTa low grade bladder tumours in the outpatient department Number of Subjects/Centres Planned: 20 patients will be included in this study. The study will be performed at Department of Urology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark. Primary Objective: To show that small pTa bladder tumours safely can be removed with diode laser in an outpatient department Secondary Objective: To evaluate the patients experience with the laser treatment using QOL questionaires (symptom evaluation) and Visual Analog Scale Score (pain evaluation).