RE:RE:RE:RE:RE:RE:Clinical Trial Inclusion Exclusion CriteriaIn this corner, Laserman, the fastest puncher in town!,, in the other corner, TdonRex, the Dino destroyer!!!! My money is on Laserman. Sorry, TdonRex, but those short arms of yours won't be able to keep Lazerman off you!!! :-))
LaserStock29 wrote: Ok NMIBC *rolls eyes*
On point 2.. learn to fuc*n read
Clinical Trials Gov Inclusion Criteria:
- Be willing and able to provide written informed consent/assent for the trial.
- Be > 18 years of age on day of signing informed consent.
- Have histologically confirmed NMIBC (T1, Ta, and/or Tis) according to the 2004 WHO classification within 8 weeks prior of treatment initiation. Participants with tumours of mixed transitional / non-transitional cell histology are eligible, but urothelial carcinoma must be the predominant histology. Participants with predominant or exclusively non-urothelial histology are not eligible. Confirmation of histology, grade and stage will be performed by local review and must be completed prior to enrolment.
- For participants with Ta and T1, they must have undergone complete TURBT defined as absence of resectable disease after at least 2 cystoscopy / TURBT procedures. The most recent cystoscopy must have been performed no longer than 8 weeks prior to the first dose of trial treatment.
tdon1229 wrote: LaserStock,
Two problems:
1. It's NMIBC, not NIMBC as you insist on rendering it
2. NMIBC includes only T0, Ta, and Tis, but _not_ T1; T1 is the beginning of MIBC. Theralase long ago anticipated a separate clinical trial for MIBC as a follow-on, assuming successful trials for NMIBC.
Also, T0 and Ta stages generally are not treated; SOC for those is "watchful waiting" since T0 shows no sign of bladder cancer and treatments applied to Ta have proven to be lacking in efficacy because of poor uptake of the applied therapy (whether chemo or BCG). Treatable NMIBC generally is limited to addressing the Tis stage indications. If there is demonstrable success by Theralase in treating both the Ta and Tis stages, then that could help change the SOC going forward.
Regards,
TDON1229