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Bladder Cancer clinical trials

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NCT ID: NCT04574960 Recruiting - Bladder Cancer Clinical Trials

Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)

NAUTICAL
Start date: February 8, 2021
Phase: Phase 3
Study type: Interventional

Upper tract urothelial cancer (UTUC) is cancer in the lining of the kidney or ureter (the tube that drains the kidney). This type of cancer is rare and as a result, there are only a few studies that have looked at it. Standard of care for UTUC would be surgery followed by chemotherapy (adjuvant chemotherapy). However, we know from studies that have looked at cancer of the lining of the bladder, which is a similar cancer in many ways, that treating people with chemotherapy before surgery (neoadjuvant chemotherapy) can lead to longer survival compared to the standard of care. There are no studies to show this in UTUC. Neoadjuvant chemotherapy is thought to help improve survival by treating any cancer that may have spread from the original tumour but that is not visible yet on scans. This study would be the first clinical trial in Canada to evaluate the use of chemotherapy before surgery in this disease setting. Since UTUC is rare, the purpose of this study is to determine if it is possible to enrol enough patients to a trial looking at the use of chemotherapy before surgery.

NCT ID: NCT04570176 Completed - Bladder Cancer Clinical Trials

Efficacy and Safety of Clinical Telesurgery Using Chinese Independently Developed Surgical Robot System

Start date: August 27, 2020
Phase: N/A
Study type: Interventional

One-arm clinical trial was adopted in this study. The surgeons performed remote urological surgery for patients through domestically produced "MicroHand" surgical robot system (Shandong Weigao Co., Ltd). The "MicroHand" surgical robot system consists of two physically separated subsystems named the "surgeon console" and "patient side cart". The surgeon console includes a stereo image viewer, two master manipulators, a control panel and several foot pedals. The patient side cart includes a passive arm that can slide in the up-down direction and be adjusted forward and backward, a swivel head that can rotate around the vertical axis, and three slave arms (one for the endoscopic camera and the other two for surgical instruments). The surgeon console (based in Qingdao) takes the surgeon's input and translates it into a control signal. After network transmission, the patient side cart (based in Anshun) translates the control signal into actual instrument manipulation. The 3D images captured by the endoscopic camera were simultaneously sent back to the screen of the surgeon console as visual feedback. Data between the surgeon console and the patient side cart were transmitted through a 5G network. The safety and effectiveness of the robotic system in remote clinical diagnosis and treatment were verified by the main judgment criterion and secondary judgment criterion. Six patients are planned to enroll in the clinical trial. Main judgment criterion: The robot-assisted telesurgery did not transfer to other types of surgery, such as open surgery or normal robot-assisted surgery. Secondary judgment criterion: operative time, blood loss, postoperative pain, preoperative adjusting time and hospitalization time. Patient enrollment: This trial aims to explore the safety and effectiveness of the domestically produced robotic system in remote clinical diagnosis and treatment through 5G network. Six patients are planned to enroll in the clinical trial, including 2 patients with adrenal tumor, 2 patients with bladder cancer and 2 patients with renal cell carcinoma.

NCT ID: NCT04567719 Active, not recruiting - Bladder Cancer Clinical Trials

Measuring Taste Perception During Chemotherapy for Muscle Invasive Bladder Cancer

Start date: March 3, 2020
Phase:
Study type: Observational

Alteration in the sense of taste is a frequent symptom that is closely linked to chemotherapy exposure, lowering quality of life and nutritional status. Malnutrition is of particular concern in muscle-invasive bladder cancer (MIBC), as malnutrition is associated with many negative outcomes from radical cystectomy (the surgical procedure in MIBC), which include higher morbidity, poor wound healing, and higher rate of infections after surgery. It is essential to understand taste changes among participants receiving chemotherapy for MIBC to create future treatment trials.

NCT ID: NCT04566393 Available - Colorectal Cancer Clinical Trials

Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies

Start date: n/a
Phase:
Study type: Expanded Access

The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who have incomplete response to or have exhausted available therapies. Ulixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agent(s), conditionally approved by the drug manufacturer.

NCT ID: NCT04564781 Recruiting - Bladder Cancer Clinical Trials

Predicting BCG Response

Start date: September 18, 2020
Phase:
Study type: Observational

To date, there are no diagnostics capable of predicting treatment response to intravesical BCG. Because of this severe limitation, nearly 50% of patients treated with BCG fail therapy and will a) require additional intravesical therapy or b) require cystectomy. A urine-based diagnostic that possesses the potential to accurately identify patients who will respond favorably to intravesical BCG is desperately needed.

NCT ID: NCT04555343 Completed - Prostate Cancer Clinical Trials

Intravesical Antifibrinolytic for Patients With Hematuria and Clot Retention

Start date: March 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

A study looking at the feasibility of doing a full-scale RCT that investigates the use of tranexamic acid intravesically prior to continuous bladder irrigation treatment in the emergency department for urinary retention due to clots. We want to know: - patient experience and acceptability of the intervention - study procedures (recruitment, site appropriateness, staff engagement) - safety data - identify resource use

NCT ID: NCT04553939 Recruiting - Bladder Cancer Clinical Trials

Neoadjuvant Toripalimab in Combination With Gemcitabine Therapy in Cisplatin Ineligible Local Advanved Bladder Cancer

Start date: January 4, 2021
Phase: Phase 2
Study type: Interventional

This is a pre-surgical study involving subjects with muscle invasive bladder urothelial cancer, who are candidates for cisplatin ineligible neoadjuvant therapy. It is a one-arm phase II study in single center.

NCT ID: NCT04543110 Recruiting - Bladder Cancer Clinical Trials

Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC

RADIANT
Start date: January 29, 2021
Phase: Phase 2
Study type: Interventional

This study assesses the effect of sequential radiation and durvalumab immunotherapy given as treatment prior to surgery with radical cystectomy for bladder cancer.

NCT ID: NCT04537221 Recruiting - Bladder Cancer Clinical Trials

Nordic Cystectomy Study III - Transfusion

NorCys-Transf
Start date: September 30, 2020
Phase:
Study type: Observational [Patient Registry]

Around 7200 cases of Muscle Invasive Bladder Cancer are diagnosed annually in the Nordic countries combined. Muscle Invasive Bladder Cancer is an aggressive disease and it is linked with high mortality rates. The golden standard of treatment is radical cystectomy (RC) (the surgical removal of the bladder) and radical removal of lymph nodes in the pelvis. In addition to surgical treatment, and especially in cases where the tumour invades tissues surrounding the bladder or lymph nodes, chemotherapy is recommended. Chemotherapy can be administered before or after surgery, in a neoadjuvant (NAC) or adjuvant setting (AC). Although most patients recover well from surgery, there are significant risks regarding radical cystectomy. The greatest challenges in planning the treatment are making individual risk assessments and prognosis for the treated patients. Neoadjuvant chemotherapy is also insufficiently used and it is hard to predict how the tumour responds to chemotherapy. The purpose of this study is to collect prospective clinical data on radical cystectomy -patients in co-operation with other Nordic countries: Sweden, Denmark, Iceland and Norway. The collected data is used to validate existing prediction tools and discover novel tools for prediction of morbidity related to RC and prediction of oncological outcome after RC. The study is divided into three sub-studies. Transfusions during RC and the time of hospitalization after the surgery are associated poorer oncological outcome when compared to those patients who do not need transfusions. The third study focuses on the oncological outcomes in patients receiving blood transfusions. As there are some conflicting reports and the finding is not properly validated, we aim to validate the effect of transfusions on survival after RC. The number of transfusions during RC and the time between surgery and discharge from hospital will be recorded. Patient cohort will be divided into patients receiving transfusions and not receiving transfusion. The primary end point is patients receiving transfusion and its effect on cancer specific mortality at 24 months. For patients receiving NAC, additional secondary end-point is complete response (pT0N0) rate at RC.

NCT ID: NCT04534309 Completed - Breast Cancer Clinical Trials

Behavioral Weight Loss Program for Cancer Survivors in Maryland

ASPIRE
Start date: September 22, 2020
Phase: N/A
Study type: Interventional

Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project