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Urologic Neoplasms clinical trials

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NCT ID: NCT03420963 Recruiting - Clinical trials for Refractory Malignant Solid Neoplasm

Donor Natural Killer Cells, Cyclophosphamide, and Etoposide in Treating Children and Young Adults With Relapsed or Refractory Solid Tumors

Start date: August 31, 2018
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of cord blood-derived expanded allogeneic natural killer cells (donor natural killer [NK] cells) and how well they work when given together with cyclophosphamide and etoposide in treating children and young adults with solid tumors that have come back (relapsed) or that do not respond to treatment (refractory). NK cells, white blood cells important to the immune system, are donated/collected from cord blood collected at birth from healthy babies and grown in the lab. Drugs used in chemotherapy, such as cyclophosphamide and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NK cells together with cyclophosphamide and etoposide may work better in treating children and young adults with solid tumors.

NCT ID: NCT03410641 Completed - Prostate Cancer Clinical Trials

Long-term Cancer Risk in the Randomised Oslo Diet and Antismoking Study

Start date: January 15, 1972
Phase: N/A
Study type: Observational

This study examines the effect of a five-year multifactorial lifestyle intervention in the Oslo diet and antismoking study on long-term cancer risk. In 1972-1973, 1232 men with high cardiovascular risk profile were randomised to intervention including cholesterol lowering diet, weight loss and antismoking advice, or control (1:1). This study examines the effect of the intervention on 43-year cancer incidence and mortality.

NCT ID: NCT03374267 Recruiting - Clinical trials for Renal Cell Carcinoma

Registry Platform Urologic Cancer

CARAT
Start date: December 7, 2017
Phase:
Study type: Observational [Patient Registry]

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced renal cell carcinoma or advanced urothelial cancer in Germany.

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: NCT03305627 Completed - Clinical trials for Surgical Site Infection

Optimized Perioperative Antibiotic Prophylaxis in Radical Cystectomy

PAPRAC
Start date: April 9, 2018
Phase: N/A
Study type: Interventional

Cystectomy with urinary diversion (ileal conduit, orthotopic ileal bladder substitute, continent catheterizable pouch) is the best treatment option for patients with muscle-invasive bladder cancer. This intervention is one of the most challenging in urology and has a high rate of postoperative complications including around 30% of postoperative infections. Perioperative antibiotic prophylaxis (PAP) is widely accepted as a crucial preventive measure to reduce the incidence of surgical site infections (SSI). The rationale for PAP is the reduction of the local bacterial load at the site and time of intervention, and therefore a short duration of PAP of 24 to maximal 48 hours is recommended for all clean to clean-contaminated procedures.. Evidence supporting the optimal duration of PAP for radical cystectomy with urinary diversion is lacking. Based on data extrapolated from abdominal surgery, current guidelines recommend short-term PAP (≤24h) for all clean-contaminated procedures including radical cystectomy. However, a recent evaluation revealed a significant inter-hospital variability of PAP and showed that extended use (>48h) was common in patients undergoing radical cystectomy. Importantly, this study also demonstrated that longer duration of PAP incurred higher costs and was associated with an increased rate of C. difficile colitis. A small, prospective, non-randomized study showed equal efficacy of short-term PAP in preventing postoperative infections in patients undergoing radical cystectomy with ileum conduit compared to extended PAP. Nonetheless, larger randomized clinical trials supporting these findings are lacking. The unwarranted extended use of antibiotics is a major concern as exposure to antibiotics is a driving force for the development of (multi-) resistant bacteria and will lead to an increasing number of difficult-to-treat infections. This has been recognized on both national and international levels and is addressed within antimicrobial stewardship frameworks. This study will compare current practice (>48h PAP, "extended PAP") with the guideline recommended approach (24h PAP, "short term PAP") in a single-centre, prospective, randomised clinical non-inferiority trial. The primary outcome is the rate of SSI within 90 days post surgery. The aim of the study is to generate currently lacking evidence allowing for an optimised PAP strategy in a challenging surgical setting.

NCT ID: NCT03288545 Active, not recruiting - Clinical trials for Urinary Bladder Neoplasms

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

EV-103
Start date: October 11, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.

NCT ID: NCT03245788 Completed - Breast Cancer Clinical Trials

Effectiveness of Lay Navigators in Meeting Cancer Patients' Non-Clinical Needs: A Pilot Study

Start date: February 15, 2017
Phase: N/A
Study type: Interventional

The Stanford Cancer Center is undertaking a Transformation Initiative in order to improve the quality of care and care coordination across the continuum of care. The newest innovation is to introduce lay navigators to specified high-need patients. The larger goal of the project is to assess whether lay navigators can address non-clinical patient needs in a timely fashion and appropriately connect them with their clinical team when warranted. It is expected that proactive interaction with patients will decrease patient anxiety/stress related to their cancer and facilitate higher patient engagement and improved management of physical, social,and emotional health. For the pilot project, the smaller goal is to understand: how lay navigator time is used; the types and frequency of issues brought up by patients; resources that patients are given or referred to; type and frequency of mode of contact with patients; and patients' acceptance of navigators based on refusal. An electronic intake form will be used to collect this information so that data can be analyzed regularly to inform changes to the navigator program as needed.

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: NCT03210376 Completed - Clinical trials for Malignant Neoplasms of Female Genital Organs

Neuromuscular Blockade on Shoulder Pain of Elderly

Start date: November 17, 2017
Phase: Phase 4
Study type: Interventional

Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a common complaint from patients who have had abdominal surgery and the pain is thought to be related to the use of IP. In addition to anesthesia (which keeps you asleep during surgery), the current standard practice is to block the nerve-muscle junction with a type of drug called neuromuscular blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of insufflation pressure is needed by the surgeon. To reverse the effects of NMB after surgery, a drug called neostigmine is given. The goal of this clinical research study is to compare the use of standard-of-care moderate NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly patients (patients who are 65 years of age or older) who are scheduled to have robotic abdominal surgery. "Deep" and "moderate" in this study refers to the dose or strength of the NMB given. This is an investigational study. Sugammadex and neostigmine are FDA approved and commercially available for the reversal of NMB. It is considered investigational to compare Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can reduce the level of shoulder pain after surgery. Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

NCT ID: NCT03204266 Completed - Clinical trials for Malignant Neoplasms of Urinary Tract

Oral Supplementation to Enhance Recovery Pilot Study

Start date: August 16, 2017
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical research study is to learn the supplements Pro-Stat (which has l-arginine and also contains protein) and omega-3 fatty acids will be well tolerated in patients who have radical cystectomy for bladder cancer. Researchers also want to learn how these medications affect inflammation and recovery for these surgical patients. This is an investigational study. Pro-Stat is not FDA-approved to treat any specific condition or disease. Omega-3 fatty acids are FDA-approved to treat high triglyceride levels. Their use to treat inflammation and help improve recovery after bladder cancer surgery is investigational. The study doctor can explain how the supplements are designed to work. Up to 46 participants will be enrolled in this study. All will take part at MD Anderson.