Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT01007058
Eligibility Criteria:
Inclusion Criteria:
Disease Characteristics:
* Histologically confirmed primary or recurrent non-muscle-invasive transitional cell carcinoma with an intact bladder
* Stage Ta, T1, or carcinoma in situ
* Grade 1, 2, or 3
* Primary disease site must be the urinary bladder
* No evidence of tumor invasion of the muscularis propria by cystoscopy and biopsy within the past 6 weeks
* Upper tract imaging within the prior 12 months
Patient Characteristics:
* Age: 18 years and above
* Gender: Male or female
* Life expectancy: 24 months or greater
* Performance status: 0 - 1
Prior Therapy:
* Biologic therapy: allowed
* Chemotherapy: allowed
* Radiotherapy: no prior pelvic radiotherapy
* Surgery: recovered from prior transurethral resection
Intravesical Immunotherapy:
* In the opinion of the treating physician, the patient must be a candidate for "standard of care" intravesical immunotherapy, defined as
* Induction with 6 weekly treatments of intravesical BCG followed by maintenance with 3 weekly treatments of intravesical BCG at 3 months. Continued maintenance therapy at 6 months and then every 6 months for total of 36 months ("Lamm regimen") (38) is optional and left to the discretion of the physician or
* Induction with 6 weekly treatments of intravesical BCG plus IFN-alfa-2b followed by maintenance with 3 weekly treatments of BCG plus IFN-alfa-2b at 3 months. Continued maintenance therapy at 9 months, and 15 months ("O'Donnell regimen") (39) is optional and left to the discretion of the physician.
* Patients will be included in the study based on 'intent to treat'. If, after start of induction, the treating physician decides to alter the treatment regimen, patients will still be included for analysis.
Special Situations:
A special situation arises when during the course of the study, a patient develops recurrent tumor, and is deemed by the treating physician to require either a reinduction course of BCG therapy or therapy with BCG plus Interferon. In that case, the patient will remain in the protocol and, since urine cytology/FISH and cytokine responses are dependent on the treatment time-table, we will start collecting urine samples all over again, as already described previously in the protocol. Also, starting from the change in the treatment plan, the patient's overall time in the protocol will be prolonged up to the completion of a 24-month period of time.
Exclusion Criteria
* Ongoing Pregnancy
* Patients who are not eligible to receive standard-of-care intravesical immunotherapy such as
* histologically confirmed pure squamous cell carcinoma or pure adenocarcinoma,
* patients with nonurothelial bladder cancer such as sarcoma, and immunocompromised patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01007058
Study Brief:
Protocol Section:
NCT01007058