How HealthKey found 16 Intermediate Risk Bladder Cancer patients in 1-Month for a Closing Bladder Cancer Trial.

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Site: US Urology Partners

Sponsor: Johnson & Johnson

Indication: Intermediate-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Specialty: Urology / Oncology

Type: Device (Intravesical Drug Delivery)

EHR: ModMed

Trial Description

Part 4 of the Phase 2 TAR-210 study (NCT05316155) tests an intravesical erdafitinib delivery system at the recommended Phase 2 dose in patients with recurrent intermediate-risk non-muscle-invasive bladder cancer. Johnson & Johnson sponsors the trial.

TAR-210 is a small device placed in the bladder that slowly releases the cancer drug erdafitinib directly onto bladder tumors. The goal is to confirm clinical benefit while reducing the need for repeated TURBT procedures.

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“Of the seven patients we enrolled, six had a complete response. Their tumors basically just melted away after three months with the pretzel inside the bladder.” Roger Li, MD, a genitourinary oncologist at Moffitt Cancer Center

Clinic Description

US Urology Partners (USUP) is a national network of urology clinics that supports practices with operations and technology so doctors can focus on patient care. For Moonrise 2 Part 4, USUP activated Central Ohio Urology Group (COUG) in Gahanna, Ohio as a trial site.

Sarah Faisal, VP of Research and Cancer Operations, directs USUP's clinical trial strategy across all brands, including the care navigation team responsible for identifying clinical trial candidates.

Challenge

USUP had an enrollment target of 4 patients. The inclusion criteria required recurrent low-grade intermediate-risk bladder cancer with no history of high-grade disease. Intermediate risk was defined as solitary low-grade tumor >3cm, multifocal low-grade tumor, low-grade T1 disease, or mixed histology where the variant histology was focal rather than predominant.

Most importantly, patients needed visible cancer >5mm in the bladder. Coordinators had to identify candidates before all visible disease was removed, which is challenging because if a surgeon identifies cancer, the standard of care is to resect it. The goal was to find eligible patients before their cystoscopy appointment and inform both doctors and patients of a potentially better chemo-ablative treatment option.

A coordinator might find a patient with documented low-grade recurrent disease, then discover in a procedure note from three weeks prior that the urologist had resected all visible tumors. That patient no longer qualified.

Without HealthKey, the alternatives were limited. USUP's remote care navigator could manually screen over 400 NMIBC patients at COUG, but she was already covering multiple USUP sites and following daily cystoscopies at each one. Alternatively, any of COUG's 21 providers could have memorized all 12 inclusion and exclusion criteria and flagged matching patients during clinical visits. But COUG had 9 other complex oncology trials in active recruitment at the same time. No physician can hold the eligibility criteria for 10 simultaneous studies in their head while seeing patients. That is why eligible patients fall through the cracks.

Solution

USUP connected HealthKey to Central Ohio Urology Group's ModMed EHR at the end of October 2025. Setup took minutes. Coordinators shared the trial protocol, and HealthKey's white-glove onboarding service translated the 12 inclusion and exclusion criteria into logic the AI could apply across both structured fields and unstructured clinical notes.

HealthKey scanned over 353,000 medical documents to filter down to 3,400 with cancer conditions, then to 431 who had visited within 6 months and were adult males. From there, patients with NMIBC were pre-screened against the full trial criteria. 16 patients passed the key intermediate-risk and BCG filters. HealthKey then evaluated those patients against all 12 eligibility criteria, running 1,972 individual criteria evaluations to identify the final eligible candidates.

Each match included supporting evidence: the pathology report confirming low-grade disease, the cystoscopy note documenting tumor size, and the procedure records showing whether disease had been fully resected. Patients with edge cases were flagged for manual review.

The Results

431 patients and 353,000 medical records processed in one month.

HealthKey screened the full bladder cancer population at Central Ohio Urology Group against all 12 eligibility criteria. Manually reviewing this volume would have taken approximately 129 hours, or 16 full working days, at the standard rate of 20 minutes per patient chart. HealthKey reduced coordinator review time to approximately 2 minutes per patient.

2 eligible patients identified, 6 more staged for recurrence.

Of 431 patients pre-screened, 16 passed the key intermediate-risk and BCG criteria. After full evaluation, 2 patients met every inclusion and exclusion criterion and 6 more were staged pending recurrence confirmation at their next cystoscopy. The first patient screen-passed within 24 hours of HealthKey's activation.

All in one month before the study closed.

HealthKey was activated at the end of October 2025. Within one month, the system had built a pipeline of eligible candidates against a target of 4 patients. The study closed enrollment in December 2025 before the full pipeline could convert. One patient identified by HealthKey was enrolled at the last minute. Another patient HealthKey flagged later developed recurrence and would have been eligible had enrollment remained open.

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"HealthKey screen-passed a patient almost immediately, and we had six more staged pending recurrence. They were real candidates. Then the study closed before we could move forward. But that proved to me we need this for Moonrise 3. There’s no way our care navigator can go through every single cystoscopy report. We're talking 200 to 300 at just one site.” Sarah Faisal, VP of Research and Cancer Operations, US Urology Partners

Looking Ahead

With Moonrise 2 enrollment closed, Sarah redirected HealthKey to new trials across the USUP network. The Moonrise 2 experience became a proof point that accelerated HealthKey's expansion.

J&J took notice, with sites calling out HealthKey by name on their bladder cancer program, and USUP immediately onboarded HealthKey for Moonrise 3.

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"We've had a several sites actually call HealthKey out specifically that they're so excited about it for our bladder cancer program." Lindsey Schulert, Director of Clinical Delivery Operations, Solid Tumor, Oncology Delivery Unit, J&J Innovative Medicine

For the care navigation team, the value was clear. HealthKey built a real patient pipeline in weeks that would have taken months to assemble manually.