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Urinary Bladder Neoplasms clinical trials

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NCT ID: NCT03327883 Completed - Bladder Cancer Clinical Trials

Retrospective Review of FDG PET MRI Management of Patients With Muscle Invasive Bladder Cancer

Start date: October 26, 2017
Phase:
Study type: Observational

Background: Bladder cancer is a common cancer in the U.S. Survival rates for metastatic bladder cancer have not gotten better for 15 years. Diagnosing and assessing the disease is important for treating it. The best way to tell what stage a cancer is in is computed tomography. This is also called CT. But it does not always give the best images of the bladder. Adding a test called positron emission tomography (PET) can help. Magnetic resonance imaging (MRI) is even better than CT for detecting bladder cancer. But it is not widely used. Some people with bladder cancer have already had MRI/PET and CT. Researchers want to study their records. They want to compare the different ways of assessing the disease. Objective: To evaluate the use of MRI/PET for diagnosing and treating metastatic bladder cancer. Eligibility: People 18 years and older who were in studies between 2013 and 2016 Design: Researchers will study existing records. There will be no active participants. The records will have no data that could identify the participants. Data will be stored on secure computers. No study participants will be contacted without approval from a review board.

NCT ID: NCT03325231 Completed - Bladder Cancer Clinical Trials

Factors Influencing Patient Choice of Bladder Reconstruction Following Radical Cystectomy

Start date: October 20, 2017
Phase:
Study type: Observational

Radical cystectomy (bladder removal) after bladder cancer necessitates surgical reconstruction to allow urine drainage. Usually, this is achieved by either ileal conduit (a stoma leads to an external bag) or orthotopic neobladder (the creation of an artificial internal bladder). These treatments are most successful when tailored to the patient's own lifestyle needs. The current project will explore patient concerns, and the aspects of their lifestyles and values, that influence their choice of bladder reconstruction. It will also examine which of these concerns and values best predict satisfaction and enhanced QoL, following bladder reconstruction. Participants will be recruited from Health Board databases of those who have had advanced bladder cancer (grade pT1 and above) and undergone either IC or NB procedures within the last five years. 40 participants (equal numbers with each surgical procedure) will be randomly selected from the patient databases. They will be interviewed by a Researcher and a Clinical Nurse Specialist. A semi-structured interview will be conducted to ascertain patients' views about the key factors influencing their treatment decision and their satisfaction with the outcome. Approximately 200 participants (equal numbers with IC and NB) will be sent three questionnaires to assess their life values, QoL, and satisfaction with treatment: (1) Bladder Reconstruction Satisfaction Questionnaire measuring levels of satisfaction with bladder reconstruction; (2) EORTC QLQ-C30 measuring QoL in areas relevant to cancer patients; and (3) Life Values Inventory measuring values and lifestyles important to patients. Participants will be asked to complete the questionnaires and return them using a prepaid envelope. Participants will be provided with the contact details of a Clinical Nurse Specialist known to them to contact if they require help completing the questionnaires.

NCT ID: NCT03319745 Completed - Clinical trials for Stage III Bladder Cancer AJCC v8

Pembrolizumab in Treating Patients With Bladder Cancer Undergoing Radical Cystectomy

Start date: January 11, 2018
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects of pembrolizumab and to see how well it works in treating patients with bladder cancer who are undergoing surgery to remove the bladder. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT03307200 Completed - Surgery Clinical Trials

Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

Start date: April 3, 2017
Phase:
Study type: Observational

Nowadays, high-quality cancer care is more than just diagnosis and treatment of cancer. Healthcare must respond to the specific needs of the patients to provide patient-centered care. To date, research on the unmet supportive care needs in bladder cancer patients undergoing radical cystectomy is scarce. Because the needs of the patients may differ according to the phase in the illness trajectory, it is important that prospective research is carried out. Research in other cancer populations shows that unmet supportive care needs are negatively associated with health-related quality of life, psychological distress, physical activity and the health literacy of the patient. By incorporating the above factors into this study, we can not only map the unmet supportive care needs of the patient, but also explore possible associations between the variables. Since this is the first prospective study on supportive care needs in bladder cancer, this is a hypothesis-generating study.

NCT ID: NCT03294304 Completed - Clinical trials for Muscle Invasive Bladder Cancer

BLASST-1 (Bladder Cancer Signal Seeking Trial): Nivolumab, Gemcitabine, and Cisplatin in Treatment of Muscle Invasive Bladder Cancer (MIBC) Undergoing Cystectomy

Start date: January 29, 2018
Phase: Phase 2
Study type: Interventional

This is a multi-center Phase II study to determine the safety and efficacy of nivolumab when given in combination with cisplatin and gemcitabine as neoadjuvant treatment in patients with muscle-invasive bladder cancer (MIBC) prior to standard of care radical cystectomy. Patients will receive neoadjuvant treatment with nivolumab in combination with gemcitabine-cisplatin (GC) every 3 weeks for 4 treatment cycles over 12 weeks followed by standard of care radical cystectomy.

NCT ID: NCT03258593 Completed - Clinical trials for Urinary Bladder Neoplasms

Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)

Start date: June 7, 2018
Phase: Phase 1
Study type: Interventional

Background: Non-muscle-invasive bladder cancer is in the early stages. But it usually comes back after treatment. The drugs Vicineum and Durvalumab may help the immune system find and destroy cancer cells. Objective: To test if the drugs Durvalumab and Vicineum together are safe and effective to treat people with bladder cancer that has not spread to the muscle in the bladder. Eligibility: People ages 18 and older who have bladder cancer that has not spread to the muscle in the bladder and was treated unsuccessfully with Bacillus Calmette-Guerin Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Tumor sample from previous surgery. If one is not available, they will have a biopsy: A small piece of tumor is removed. Cystoscopy to examine the inside of the bladder. This may include a biopsy or removing tumors. Computed tomography (CT) or magnetic resonance imaging (MRI): They lie in a machine that takes pictures of the body. Electrocardiogram to test heart function Participants will receive Durvalumab and Vicineum in 2 phases: First phase: Durvalumab every 4 weeks and Vicineum once a week for 3 months Second phase: Durvalumab every 4 weeks and Vicineum once every other week Participants will have tumor samples taken every 3 months. They will have blood and urine tests throughout the study. Participants will continue treatment for up to 2 years. Participants will have a visit about 30 days after their last treatment. This includes blood and urine tests. It may include a cytoscopy or additional biopsies.

NCT ID: NCT03229278 Completed - Lymphoma Clinical Trials

Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma

Start date: October 3, 2017
Phase: Phase 1
Study type: Interventional

This phase I trial studies the best dose and side effects of trigriluzole in combination with nivolumab and pembrolizumab in treating patients with solid malignancies or lymphoma that has spread to other places in the body or cannot be removed by surgery. Trigriluzole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as nivolumab and pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving trigriluzole in combination with nivolumab and pembrolizumab may work better at treating patients with solid malignancies or lymphoma.

NCT ID: NCT03219333 Completed - Clinical trials for Urinary Bladder Neoplasms

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer

EV-201
Start date: October 8, 2017
Phase: Phase 2
Study type: Interventional

This is a study that will test how an experimental drug (enfortumab vedotin) affects patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra that has spread to nearby tissues or to other areas of the body. This clinical trial will enroll patients who were previously treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). Some CPIs have been approved for the treatment of urothelial cancer. This study will test if the cancer shrinks with treatment. This study will also look at the side effects of the drug. A side effect is a response to a drug that is not part of the treatment effect. Patients who sign up for this trial must also fall into one of these categories: - Patients have already received treatment with platinum-containing chemotherapy - Patients have never received platinum-containing treatment and are not eligible for treatment with cisplatin.

NCT ID: NCT03212651 Completed - Bladder Cancer Clinical Trials

Study Evaluating Neoadjuvant Pembrolizumab Monotherapy in Patients With Muscle-Invasive Bladder Cancer to Explore in Vivo the Mechanisms of Action of Pembrolizumab

PANDORE
Start date: October 17, 2017
Phase: Phase 2
Study type: Interventional

monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2; Recent phase I trial provided evidence of activity of pembrolizumab in advanced platinum-resistant metastatic urothelial carcinoma; Recent phase 3 trial showed an overall survival benefit in patients treated with pembrolizumab in a trial comparing pembrolizumab to chemotherapy in patients who failed first-line platinum-based chemotherapy Neoadjuvant chemotherapy followed by radical cystectomy is the standard of care for cisplatinum-eligible non-metastatic MIBC patients; Many patients with MIBC are unfit for cisplatin-based combination treatment; Given its safety profile, pembrolizumab may be used in unfit patients; Neo-adjuvant setting is a unique opportunity to assess mechanisms of action of pembrolizumab in human

NCT ID: NCT03191578 Completed - Clinical trials for High-Risk Non-Muscle-Invasive Bladder Cancer

Immunological Response to Intravesical BCG Therapy of Superficial Bladder Cancer by Prior Administration of RUTI®

RUTIVAC-1
Start date: June 16, 2017
Phase: Phase 1
Study type: Interventional

The RUTIVAC-1 study is a Phase I Clinical Trial designed to evaluate the systemic and mucosal immunological response and provide safety information after the use of RUTI® administration to individuals with NMIBC. The study will enroll individuals treated with Transurethral resection of bladder tumor (TURBT), diagnosed to have high-risk Non-muscle invasive bladder cancer (NMIBC) and suitable candidates for BCG therapy and who meet all eligibility criteria. Forty individuals will be recruited and randomized 1:1 to receive two subcutaneous shots of 25 μg RUTI® or placebo. After vaccination, individuals will receive the standard induction course, of intravesical Bacillus Calmette-Guerin (BCG)therapy (weekly BCG for six weeks). 4 to 8 weeks after the last intravesical BCG administration (BCG6) a visit will be performed (Visit 1, end of the interventional phase). Once all participants have performed VISIT 1 immunological assays will be performed and data will be analyzed. At the end of the Interventional Phase the blind will be opened, except for the study physicians who will remain blind during all the follow-up. All the individuals will be followed up for three years since TURBT.