Non-muscle-invasive bladder cancer is judged by what a urologist sees and a pathologist reads: cystoscopy, cytology and biopsy, on a fixed calendar, with recurrence the event that matters. Capture holds the procedures, the instillation log and the pathology in one study. Build it in the free sandbox, no credit card, and pay only at go-live.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Assessment | Screen | Wk 1-6 induction | Mo 3 | Mo 6 | Mo 9 | Mo 12 |
|---|---|---|---|---|---|---|
| Intravesical instillation | ||||||
| Cystoscopy | ||||||
| Urine cytology | ||||||
| Biopsy (mapping or directed) | ||||||
| Urinary symptom diary | D | D | D | D | D | |
| Adverse events |
x = visit form, D = participant diary entries
What a bladder cancer trial needs from its EDC
The study data
Bladder cancer trials split along a clinical line. Non-muscle-invasive disease (Ta, T1 and carcinoma in situ) is managed by transurethral resection and intravesical therapy, with BCG the long-standing standard. Trials in BCG-unresponsive disease test intravesical agents, gene therapies and checkpoint inhibitors. In registered CIS trials the primary endpoint is complete response, typically defined as negative cystoscopy, negative urine cytology and, in many protocols, a negative biopsy at a prespecified time such as month 6 or week 25. Durability of response is then reported with Kaplan-Meier methods. For high-grade papillary disease without CIS, event-free survival or high-grade-recurrence-free survival is the usual measure.
Muscle-invasive disease (T2 and above) is a systemic-therapy and surgery problem. Perioperative trials with cisplatin-based chemotherapy, immunotherapy or antibody-drug conjugates use pathological complete response at cystectomy, event-free survival or overall survival, and the forms centre on staging, surgery, pathology and toxicity. The metastatic setting looks like any other solid tumour: RECIST response and survival, covered in EDC for oncology clinical trials.
What makes the NMIBC dataset awkward is that the primary result is a composite of three separate procedures on three separate dates. The cystoscopy may be on day 168, the cytology reported on day 171 and the biopsy slide read a week later. If those are filed on one visit form, the response call sits next to its evidence. If they are filed on three unlinked sheets, you spend database lock matching dates.
Build one response form per assessment timepoint with sections for cystoscopy findings, cytology category, and biopsy result (with a "not required" option so the protocol rule is explicit). Add a derived or reviewer-entered response field, and a query when cytology is positive but cystoscopy is recorded as normal, as that combination often needs adjudication under your protocol. Capture applies the rule you write and keeps the history; it does not interpret findings clinically.
Procedures
Cystoscopy date
CYSDATCystoscopy finding
CYSFNDUrine cytology
CYTRESCytology not negative while cystoscopy is clear: confirm
Biopsy
BXRESProtocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Baseline disease | Stage, grade, CIS component, number of prior BCG courses | Medical and oncologic history forms; medical history eCRF as a start |
| Intravesical instillations | Date, agent lot, volume, dwell time, completed or interrupted | Repeating table section, one row per instillation |
| Response assessments | Cystoscopy, cytology, biopsy per timepoint | One response form per timepoint, three sections |
| Pathology | Local read, central read, grade and stage | Pathology form with two result blocks |
| Recurrence and progression | Date, grade, stage, treatment (cystectomy) | Event form; each event is a dated record |
| Performance status | ECOG for systemic arms | ECOG eCRF |
| Urinary symptoms | Frequency, urgency, dysuria, haematuria | Participant diary on a phone link |
| Adverse events | Bladder irritation, systemic reactions, immune-related events | Adverse event form with CTCAE grading |
Response definitions vary by trial and regulator. The table shows layout, not a definition of response.
Build the instillation log and response assessment in the free sandbox and let the principal investigator test it. No credit card.
Intravesical therapy
Instillation therapy has its own data. Each treatment is given in clinic through a catheter and held in the bladder for a protocol-specified time; interruptions, catheterisation difficulty and early voiding change how much drug was delivered. Record each instillation as a row in a table section with date, product lot, dwell time and a completion field, and add a reason field for missed or shortened treatments. The result is a dose-intensity dataset you can export, instead of a nursing note reconciled later. Where the product is supplied under blinding or in kits, the Full Platform plan includes drug supply tracking; see IMP inventory and drug accountability.
Local toxicity is expected: cystitis symptoms, urinary frequency, haematuria and urinary tract infection. Systemic exposure from BCG, though uncommon, needs fast recognition. Capture records onset, severity and relationship on the adverse event form, routes serious events through the SAE sign-off, and lets edit checks highlight combinations such as fever within a few days of an instillation for the safety reviewer to look at. These checks surface a data pattern; clinical response to fever follows your protocol, not the EDC.
Patient-reported urinary symptoms and quality of life are increasingly secondary endpoints, because bladder preservation is part of the value of an intravesical agent. Diaries and generic instruments can be completed on the participant's phone, with reminders; see EDC for quality-of-life studies. Licensed instruments stay licensed through their rights holders.
Before first participant
Which procedures, which timepoints, which rule when they disagree.
Mapping versus directed, and a "not required" option so absence is intentional.
Lot, volume, dwell time, completion and missed-dose reason.
Which result is primary and how a discordant read is queried.
Month 3 and month 6 windows wide enough to schedule a theatre slot.
CSV or Excel with data dictionary; SDTM as SAS XPT with Define-XML for submission datasets.
Muscle-invasive and metastatic
Perioperative trials add forms that NMIBC studies never need: neoadjuvant cycles, cystectomy date and surgical approach, lymph node count, pathological stage (ypT, ypN) and margin status, then adjuvant therapy and surveillance imaging. Pathological complete response is read from the surgical specimen, so the pathology form carries more weight than any clinic assessment. Advanced disease uses RECIST target lesions, treatment cycles and survival follow-up; see EDC for prostate cancer trials for the neighbouring genitourinary design and the ovarian cancer page for how a different solid tumour handles response.
Older participants with renal impairment are common, so cisplatin eligibility, creatinine clearance and hearing or neuropathy assessments sit in the baseline and safety forms. Capture can calculate eGFR and Cockcroft-Gault clearance from entered values, shown read-only. Multi-site oncology programmes use QR-code enrolment, site numbering and by-site filtering; see multi-site clinical trial management.
Yes. Build one response form per timepoint with a section for each procedure and a response field. The rule that combines them is defined in your protocol and analysis plan; edit checks can query disagreement.
In a table section with one row per instillation (date, lot, volume, dwell time, completed or interrupted). Each row has its own audit trail.
Capture records each recurrence or progression as a dated event with grade and stage. Time-to-event derivations are done in your analysis, on exported data.
Yes, as separate result blocks on one pathology form. Capture does not host slide images; image handling is outside the product.
Yes. Forms for neoadjuvant cycles, cystectomy, pathology and adjuvant therapy are built from your protocol, as they are for any oncology study.
Yes, through a diary that opens from a secure phone link, with reminders and a completion window.
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Free sandbox with every feature. No credit card, and you pay only when you go live.