Non-muscle Invasive Bladder Cancer Clinical Trial
Official title:
A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer
Prior to performing any study specific procedure (including screening procedures to determine eligibility), a signed consent form will be obtained for each subject. Patients will be enrolled in the study only if they meet all the inclusion criteria and none of the exclusion criteria. Prior to perform any study specific procedure (including screening procedures to determine eligibility), a signed informed consent form will be obtained for each subject. The informed consent form will describe the purpose of the study, the procedures to be followed, and the risk and benefits of participation. The investigator will conduct the informed consent discussion and will check that the subject comprehends the information provided and will answers any questions about the study. Consent will be voluntary and free from coercion. The investigator that will conduct the consent discussion will also sign the informed consent form. A copy of the informed consent form will be given to the subject and the fact that the subject has been consented to the study will be documented in the subject's record. When all the inclusion and exclusion criteria have been addressed and the eligibility of the subject confirmed, the subject may be enrolled in the study. The following activities and/or assessments will be performed during screening, prior the treatment period start: demographic, medications related to the disease or symptoms and cancer history data collection; Urine-colture; randomization; Questionnaires QoL e IPSS. BCG or MMC will be started within 1-2 weeks from randomization (within 4-6 weeks after TURB). BCG or MMC will be administered once a week by intravesical instillation: BCG will be abministered for 6 weeks and MMC for 8 weeks. (induction cycles) Before instillations a physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes. IPSS questionnaire and QoL questionaire will be administered to the patient at week 1, 4 and 6/8 (6 for BCG and 8 for MMC) of treatment. 48 hours after post BCG or MMC intravesical instillation, patients of Arm A will undergo Hydeal Cyst intravesical instillation. BCG patiens will received 6 Hydeal Cyst intravesical instillation; MMC patiens will received 8 Hydeal Cyst intravesical instillation. After 2 weeks from BCG or MMC instillation end, IPSS e QoL questionaires will be administered and a control urino-colture will be executed. After 6 and 12 weeks from instillation therapy end, a control visit will be made. A physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes. Control cystoscopy and urino-colture will be executed (as for clinical practice) and IPSS and quality of life evaluated.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04736394 -
A Phase 3 Study to Evaluate the Safety and Efficacy of APL-1202 as a Single-agent Oral Treatment Versus Intravesical Instillation of Epirubicin Hydrochloride in naïve Intermediate-risk NMIBC Patients
|
Phase 3 | |
Recruiting |
NCT05951179 -
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
|
Phase 2 | |
Active, not recruiting |
NCT04943094 -
Clinical and Functional Consequences of Photodynamic Diagnosis (PDD) and Intravesical Instillation Therapy
|
||
Not yet recruiting |
NCT06227065 -
Precise Neoadjuvant Chemoresection of Low Grade NMIBC
|
Phase 2 | |
Completed |
NCT02969109 -
Validation of a Urine-based Assay With Genomic Markers for Predicting Recurrence for Non-muscle Invasive Bladder Cancer
|
||
Completed |
NCT01458847 -
Cis-urocanic Acid (Cis-UCA) in Patients With Primary or Recurrent Non-muscle Invasive Bladder Cancer
|
Phase 1 | |
Recruiting |
NCT03914794 -
A Study of Pemigatinib in Non-muscle Invasive Bladder Cancer Patients With Recurrent Low- or Intermediate-Risk Tumors
|
Phase 2 | |
Recruiting |
NCT05126472 -
Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment
|
Phase 1 | |
Recruiting |
NCT04644835 -
Low Energy Shock Wave Therapy and Non-Muscle Invasive Bladder Cancer
|
N/A | |
Recruiting |
NCT06126796 -
Urine-based Molecular Testing vs Cystoscopy for Surveillance of Nonmuscle Invasive Bladder Cancer (NMIBC)
|
||
Active, not recruiting |
NCT04100733 -
Surveillance of High-grade Non-muscle Invasive Bladder Tumours Using the Xpert Bladder Cancer Monitor
|
N/A | |
Recruiting |
NCT05085990 -
Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
|
Phase 1 | |
Recruiting |
NCT03560479 -
A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT01310803 -
Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder
|
Phase 3 | |
Completed |
NCT03081858 -
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT04498702 -
Study of Continuous APL-1202 Treatment in Subjects With High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Relapsed From Intravesical Chemo/BCG Therapy
|
Phase 2 | |
Recruiting |
NCT05337397 -
Outpatient Laser Ablation of Recurrent Non-muscle Invasive Bladder Cancer
|
||
Active, not recruiting |
NCT04490993 -
Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients
|
Phase 3 | |
Recruiting |
NCT04859751 -
Study of VB4-845 Injection for Treating Patients With Non-muscle Invasive Bladder Cancer
|
Phase 3 | |
Recruiting |
NCT05672615 -
Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG
|