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Bladder Cancer clinical trials

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NCT ID: NCT05856825 Not yet recruiting - Bladder Cancer Clinical Trials

Long-Term Outcomes of Robot-Assisted Radical Cystectomy: A Real-World Study

Start date: May 1, 2023
Phase:
Study type: Observational

A multicenter, retrospective research was conducted. Patients who underwent robot-assisted radical cystectomy (RARC) from for bladder cancer in 32 institutions in China were enrolled in this study. Baseline condition, perioperative, pathological, and survival outcome were collected. The study was aimed to report the real-world condition of RARC in China, and evaluate its effectiveness.

NCT ID: NCT05846165 Not yet recruiting - Bladder Cancer Clinical Trials

InveStigAting Bladder fiELd-cycLing imAging

ISABELLA
Start date: May 2023
Phase: N/A
Study type: Interventional

The goal of this pilot study is explore the parameters that can be obtained in bladder tumours by Field-Cycling Imaging (FCI) in patients with both muscle-invasive and non-muscle invasive tumours. The main question it aims to answer is if FCI can give more diagnostic information than conventional tests. Participants will have one FCI scan and the results will be correlated with the results of CT urogram or CT scan.

NCT ID: NCT05837767 Recruiting - Pancreatic Cancer Clinical Trials

A Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue

Start date: July 24, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to find out whether lattice radiation therapy (LRT) is an effective radiation therapy technique when compared to standard stereotactic body radiation therapy (SBRT). The study will also study how the different radiation therapy techniques (LRT and SBRT) affect how many immune cells are able to attack and kill tumor cells (immune infiltration).

NCT ID: NCT05833997 Recruiting - Bladder Cancer Clinical Trials

Safety Analysis and Oncological Outcomes in HoLERT vs TURBT

Start date: December 10, 2020
Phase: N/A
Study type: Interventional

Bladder urothelial cancer is the second most common urologic tumor and represents a worldwide public health problem. Most cases are diagnosed as non-muscle invasive tumors, and can be treated with transurethral resection of bladder tumor (TURBT). However, the electrical energy-based TURBT fragments the tumor, burning it to its own muscular layer leading to artifacts that may spoil the histopathological analysis, resulting in understaging after the first TURBT ranging from 30-64%, depending on the presence of detrusor muscle. Modern laser technologies have been emerging as an alternative to classical TURB using en bloc tumor resection technique (ERBT). Therefore, the laser is applied on tumor's pedicle to resect the whole and intact tumor without fragmentation or fulguration as occurs in TURBT. The purpose of using laser if to improve the resection quality, decrease intra and perioperative complications, avoid re-TURBT and reduce recurrence rates at the resection site and in distant sites. Thus, the purpose of this study is to evaluate Laser Holmium use for large tumors resection (>3cm), reducing complications, costs, and the need for new approaches, and improving the muscle layers samples.

NCT ID: NCT05829057 Recruiting - Ovarian Cancer Clinical Trials

The IIT Study of Evaluation of P-IL-2 Single Agent and With Anti-PD-1

Start date: May 23, 2023
Phase: Phase 1
Study type: Interventional

Phase Ia: single-dose escalation study: accelerated titration combined with traditional "3+3" dose. Sample size is correlated with the DLT occurring in each dose group. 4 dose groups are expected; the first dose group is the accelerated titration group, which includes only 1 subject; subsequent dose groups are in traditional "3+3" dose increments, with 3-6 subjects in each group; a total of 10-19 subjects are expected in all dose groups. If the DLT is still not present in the highest dose ,the safety monitoring committee(SMC) to determine if it is necessary to continue incrementally to a higher dose.

NCT ID: NCT05827614 Recruiting - Breast Cancer Clinical Trials

Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), in Subjects With Tumors With Oncogene Amplifications

POTENTIATE
Start date: March 24, 2023
Phase: Phase 1
Study type: Interventional

BBI-355 is an oral, potent, selective checkpoint kinase 1 (or CHK1) small molecule inhibitor in development as an ecDNA (extrachromosomal DNA) directed therapy (ecDTx). This is a first-in-human, open-label, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-355 administered as a single agent or in combination with select therapies.

NCT ID: NCT05824299 Not yet recruiting - Bladder Cancer Clinical Trials

Influence of Anesthesia Methods on CTCs in TURBT Patients

Start date: August 15, 2023
Phase: N/A
Study type: Interventional

Multiple lines of evidence have shown that anesthesia method is associated with long-term outcomes in patients undergoing surgery due to cancers, including lung, breast, prostate, and bladder cancer, etc. Circulating tumor cells (CTCs) have been validated as prognostic biomarkers of a number of cancers. The aim of this study is to investigate the effects of anesthesia methods on the number of CTCs in patients receiving transurethral resection of bladder tumor (TURBT). The difference of anesthesia method is achieved by using general anesthesia in one group and spinal anesthesia in the other group.

NCT ID: NCT05819827 Recruiting - Prostate Cancer Clinical Trials

Associations Between Chemotherapy-Induced Nausea in Patients With Genitourinary, Sarcoma or Melanoma Cancers and Changes in Gut Microbiome: Potential for Precision Therapeutics

Start date: April 19, 2023
Phase:
Study type: Observational

The objective of this pilot cohort study is to investigate associations between CIN and changes in gut microbiome composition profiles.

NCT ID: NCT05810623 Not yet recruiting - Bladder Cancer Clinical Trials

Single-Dose Intravesical Chemotherapy After Diagnostic URS

MINERVA
Start date: June 1, 2023
Phase: Phase 3
Study type: Interventional

Study design This study is a Phase III, randomized, open-label, multi-center, global study to determine the efficacy of a single immediate intravesical chemotherapy instillation (SI) in the prophylaxis of intravesical recurrence after diagnostic uretero-renoscopy (URS) of patients 18 years of age or older with the fist diagnosis of UTUC. This study will randomize 394 patients globally Patients will be randomized in a 1:1 ratio to the interventional arm or to observation. Study period This study will include a screening period, a treatment and disease assessment period, safety follow-up visits and a 5-year survival follow-up period to begin immediately after the treatment. Screening period: The period up to 28 days prior to intervention during which the screening procedures occur. Treatment and disease assessment period: The period starting the day of diagnostic URS (Day 0) during which patients receive their assigned treatment (Day 0 to day 1) and disease assessments are performed. All patients must follow the disease assessment schedule, which includes disease assessments at screening and every 3 months (±1 week) from the date of intervention until 24 months from the date of randomization, and then every 6 months for up to 5 years. The treatment and disease assessment period will end at the time of intravesical recurrence, death, or MINERVA-CTU decision to terminate the trial early. Safety follow-up visits: Every patient in this study will be assessed for the occurrence of adverse events (AEs) and serious adverse events from the time of signed informed consent until 90 days after the administration of SI. All patients who receive SI will have safety visits 4, 8, and 12 weeks following administration of SI. Safety assessments include targeted physical examination, complications according to Dindo-Clavien classification and patient-reported outcomes (PRO) assessments. Survival follow-up period: Patients will be followed up at in-clinic site visits, by telephone contact, or by contact with the patient's current physician for up to 5 years from the date of randomized into this study. Objectives Primary objective Efficacy of a SI in the prophylaxis of intravesical recurrence after diagnostic URS for UTUC Secondary objectives - Time to intravesical recurrence - 5-years intravesical recurrence rates - Incidence of high-grade BCa recurrence - Incidence and gravity of adverse events (AEs) due to the SI - To collect and store blood, urine and tissue samples according to each country's local and ethical procedures for identifying candidate markers that may correlate with likelihood of clinical benefit (optional) - To collect and store DNA according to each country's local and ethical procedures for future exploratory research into somatic mutations and genes/genetic variations that may influence oncologic outcomes, to study treatments and susceptibility to disease (optional) - To assess disease-related symptoms and HRQoL in patients with UTUC treated with SI compared those undergoing observation - To assess patient-reported treatment tolerability directly using specific PRO-CTCAE symptoms Target study population The study population includes patients 18 years of age or older with a primary diagnosis of UTUC, scheduled for diagnostic URS Duration of treatment Patients randomized to the interventional arm will receive a SI within 24h after diagnostic URS. In case of multiple diagnostic URS during the follow-up (including 2nd look for incomplete ablation, non-diagnostic first URS or UTUC recurrence) patients randomized to the interventional arm will receive a SI after each diagnostic URS for 2 years after the day of first diagnostic URS. Follow-up of subjects post discontinuation of study treatment Patients who have discontinued study treatment due to toxicity, symptomatic deterioration, intravesical recurrence or investigator's decision will be followed up for survival until 5 years from the date of diagnostic URS. Survival All randomized patients, regardless of disease status, will be followed up for survival until 5 years from the date of diagnostic URS. Investigational product, dosage, and mode of administration Patients randomized to the interventional arm will receive a SI. The chemotherapy will be at investigator's discretion and institutional availability. The selected chemotherapy must be approved by the MINERVA-CTU in discussion with the local investigator. Statistical methods This study will randomize 394 patients globally. Patients will be randomized 1:1 to SI or observation. Randomization will be stratified by the following factors: 1. Center 2. EAU UTUC risk stratification

NCT ID: NCT05799456 Completed - Bladder Cancer Clinical Trials

Glycosaminoglycan Scores as Early Detection Biomarkers in Bladder Urothelial Carcinoma

Start date: October 1, 2018
Phase:
Study type: Observational

Early detection of bladder cancer (BCa) is considered an effective strategy to curb mortality from the disease. However, current urinary biomarkers have insufficient specificity to warrant BCa screening. Urine free glycosaminoglycan profiles (or GAGomes) are promising noninvasive biomarkers of cancer metabolism. In this study, samples are obtained from patients with BCa and controls to compare the glycosaminoglycan profiles between groups.