Non-Muscle Invasive Bladder CarcinomaPhase 1/2NCT07874347
Home-Based Outpatient Model for BCG Delivery to Reduce Undue Burden on Patients Undergoing Treatment for Non-Muscle Invasive Bladder Carcinoma
A Phase 1/2 study testing BCG Solution, Best Practice and Cystoscopy in people with Non-Muscle Invasive Bladder Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase I/II trial tests the feasibility of home based BCG delivery to reduce undue burden on patients undergoing treatment for non-muscle invasive bladder carcinoma. Bacillus Calmette Guerin (BCG) is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Muscle Invasive Bladder Carcinoma
- What is being tested?
- BCG Solution, Best Practice and Cystoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2027to 31 Dec 2028
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age at the time of enrollment
- Able and willing to provide signed informed consent, confirming voluntary participation and understanding of study-related information and procedures
- Determined by the investigator to be capable and willing to comply fully with the study protocol, including the independent or assisted completion of required questionnaires
- Pathological confirmation of NMIBC, with transurethral resection of bladder tumor (TURBT) completed within the past 6 weeks. In cases of cT1, the 6-week window may apply from the date of a second TURBT, if performed
- Clinically confirmed to be intermediate or high risk according to the American Urological Association (AUA)/Society of Urologic Oncology (SUO) risk stratification system:
- Intermediate risk: recurrent low-grade Ta, solitary low-grade Ta > 3 cm, multifocal lowgrade Ta, low-grade T1, or high-grade Ta ≤ 3 cm.
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- High risk: any high-grade T1, recurrent high-grade Ta, high-grade Ta > 3 cm or multifocal, any carcinoma in situ (CIS), any BCG failure in a high-grade patient, any variant histology, lymphovascular invasion, or high-grade prostatic urethral involvement
- Decision to proceed with adjuvant intravesical Bacillus Calmette-Guérin (BCG) therapy
- No exposure to BCG within the previous year
- Subject agreement that their home:
- is safe;
- will permit a medical visitor to enter; and
- has a private space free from pets and small children
- Ability to abstain from voiding for at least two hours
- Resides within the geographical service area of the affiliated home health service supporting the study
- Has reliable access to technology for remote video consultations or telephone communication, enabling necessary follow-up and safety monitoring
Who cannot join
- History of intravesical Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma within the past 12 months
- Presence of serious systemic conditions or other active diseases (including severe lung disease) that, in the opinion of the investigator, would render the participant unsuitable for the study or compromise the evaluation of safety and tolerability of the study treatment
- Current enrollment in another investigational drug or device study
- History of complicated or traumatic urethral catheterization
- History of severe voiding dysfunction, uncontrolled urinary incontinence or any other condition that may impair adequate BCG dwell time
- Previous severe adverse reaction or intolerance to BCG therapy
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- Immunocompromised state (e.g., HIV with CD4 count < 200 cells/mm^3, solid organ transplant, or active immunosuppressive therapy)
- Significant cognitive impairment or psychiatric disorder that may interfere with adherence to the study protocol
- Pregnant or currently breastfeeding individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Cheryl T. Lee, MD, 614-293-4696, Lee.7957@osu.edu
Cheryl T. Lee, MD
About this study
Official title: Home-Based Outpatient Model for BCG Delivery: Reducing Undue Burden of NMIBC Treatment (Home-Run) Trial
This phase I/II trial tests the feasibility of home based BCG delivery to reduce undue burden on patients undergoing treatment for non-muscle invasive bladder carcinoma. Bacillus Calmette Guerin (BCG) is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. For patients with bladder cancer it is used in a solution and placed directly into the bladder to stimulate the immune system to attack the cancer cells. Bladder cancer patients often face frequent clinic visits for BCG treatment, creating time, cost, and require help from caregivers or family members. BCG treatment may be able to be given at home which would improve access and quality of care without compromising treatment effectiveness for patients with non-muscle invasive bladder carcinoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of home-based delivery of intravesical BCG therapy as measured by successful administration of BCG therapy in at least four of five in-home induction doses.
II. To evaluate the correct administration of intravesical BCG.
SECONDARY OBJECTIVES:
- To evaluate the proportion of patients achieving an adequate therapy regimen, defined as at least five of six induction instillations (including the first in-clinic dose) plus at least two of three maintenance instillations.
II. To evaluate the safety of home-based intravesical BCG, measured by the incidence, type, and severity of treatment-emergent adverse events (TEAEs) graded per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0, including predefined events of interest (symptomatic urinary tract infection [UTI], fever > 38.5 °C, urosepsis, local/distant BCG-related granulomatous reactions, reactive arthritis, and moderate- severe lower urinary tract symptoms (LUTS): dysuria, frequency, urgency, hematuria).
III. Compare the cost of home-based therapy to in-office therapy. IV. Assess patient reported outcomes related to IVa. Quality of life; IVb. Satisfaction with care; IVc. Treatment-related burden. V. Measure treatment response defined as the absence of visible tumor during cystoscopy combined with negative urine cytology at 3- and 6-month surveillance points.
OUTLINE:
Patients receive BCG instilled into the bladder, for a goal of 2 hours, once per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo cystoscopy and patients with no cancer identified receive BCG instilled into the bladder, for a goal of 2 hours, once per week for 3 weeks, starting 1-2 weeks post cystoscopy. The first installation is administered in a hospital-based clinical setting for initial observation, all subsequent treatments are delivered in the patient's home by trained home health nurses. Participants receive emergency contact information, including the telephone number for the 24-hour triage line and instructions for contacting the on-call urologist, to report any suspected exposure or treatment-related concerns.
After completion of study treatment, patients are followed up at 3 and 6 months.
- Conditions
- Non-Muscle Invasive Bladder Carcinoma
- Being tested
- BCG Solution, Best Practice, Cystoscopy, Home Health Encounter, Survey Administration
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG SolutionBiological
Also called Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG Solution
Given via installation in the bladder
Best PracticeOther
Also called standard of care, standard therapy
Receive BCG in a hospital-based clinical setting
CystoscopyProcedure or surgery
Also called CS
Undergo cystoscopy
Home Health EncounterOther
Also called HH, Home, Home Care Visit, Home Health
Receive BCG installation at home by trained home health nurses
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Health services research (Home based BCG delivery) | Experimental | Patients receive BCG instilled into the bladder, for a goal of 2 hours, once per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo cystoscopy and patients with no cancer identified receive BCG instilled into the bladder, for a goal of 2 hours, once per week for 3 weeks, starting 1-2 weeks post cystoscopy. The first installation is administered in a hospital-based clinical setting for initial observation, all subsequent treatments are delivered in the patient's home by trained home health nurses. Participants receive emergency contact information, including the telephone number for the 24-hour triage line and instructions for contacting the on-call urologist, to report any suspected exposure or treatment-related concerns. Receives: Biological: BCG Solution; Other: Best Practice; Procedure: Cystoscopy; Other: Home Health Encounter; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful administration of Bacille Calmette Guerin (BCG) therapy in at least four of five in-home induction doses (feasibility)
Feasibility will be considered achieved if ≥ 85% complete ≥ 4 of 5 induction and ≥ 2 of 3 maintenance doses. Feasibility will be considered acceptable if the lower bound of the 95% confidence interval exceeds the pre-specified threshold of 70%. The estimated completion proportion will be reported with an exact 95% Clopper-Pearson confidence interval.
Measured: Up to 6 months
Ability to reconstitute TICE BCG
Successful reconstitution of one vial of TICE BCG in 50 mL of sterile preservative-free saline
Measured: Up to 6 months
Correct installation technique
Defined as administration of reconstituted TICE BCG through a urethral catheter into the bladder.
Measured: Up to 6 months
Completion of post instillation instructions to attempt to retain the BCG solution
Completion of post instillation instructions to attempt to retain the BCG solution for approximately 2 hours, or until the patient develops a strong urge to urinate. This will be measured in minutes from instillation to voiding and recorded by the research team during a follow-up telephone call.
Measured: From instillation to voiding, assessed up to 3 hours
Incidence of post BCG adverse events
Defined as evaluation of any symptoms or adverse effects occurring after BCG therapy.
Measured: Up to 6 months
Secondary outcomes (6)
Proportion of patients achieving an adequate therapy regimen
Defined as at least five of six induction instillations (including the first in-clinic dose) plus at least two of three maintenance instillations.
Measured: Up to 6 months
Incidence of treatment-emergent adverse events (AE)
Graded per Common Terminology Criteria for Adverse Events version 6.0, including predefined events of interest (symptomatic urinary tract infection, fever > 38.5 °C, urosepsis, local/distant BCG-related granulomatous reactions, reactive arthritis, and moderate- severe lower urinary tract infection: dysuria, frequency, urgency, hematuria). Occupational exposure incidents among trained home health nurses will also be captured. Descriptive statistics will be used for laboratory abnormalities and physical findings. Kaplan-Meier analysis with log-rank tests may be applied descriptively to assess time to first grade ≥ 3 AE.
Measured: Up to 6 months
Cost of home-based therapy versus in-office therapy
Patient-reported questionnaires will capture direct out-of-pocket expenses, travel and parking costs, time spent commuting, and caregiver involvement. Responses will be analyzed descriptively, and paired comparisons between the in-clinic and home-based settings (for the first induction dose) will be performed. Continuous outcomes (e.g., travel time, caregiver hours) will be compared using paired t-tests or Wilcoxon signed-rank tests, depending on the distribution. Categorical outcomes (e.g., missed work, caregiver assistance) will be compared using McNemar's test.
Measured: Up to 6 months
Satisfaction with care
Responses will be summarized descriptively and compared between in-clinic and home-based treatment using Wilcoxon signed-rank tests. Exploratory ordinal logistic regression may be used to identify predictors of high satisfaction.
Measured: Up to 6 months
Treatment-related burden
A treatment burden questionnaire will be administered weekly after each treatment. The questionnaire is Adapted from the Treatment Burden Questionnaire (TBQ) and the Functional Assessment of Cancer Therapy-Bladder (FACTBl).
Measured: Up to 6 months
Treatment response
Defined as the absence of visible tumor during cystoscopy combined with negative urine cytology at 3- and 6-month surveillance points. Will be summarized as proportions with exact 95% Clopper-Pearson confidence intervals.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start15 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Lee, Ohio State University Comprehensive Cancer Center
- Investigators
- Cheryl T Lee, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874347
- Sponsor's protocol ID
- OSU-26030
- Other IDs
- NCI-2026-06913, STUDY20260504, OSU-26030
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No