Chemokeyp: A Feasibility Study for Realtime Safety Data-Capture for Potential Serious Adverse Drug Events

NCT07592234 | Recruiting

• 1 other identifier: RS25-062
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Chemokeyp is a feasibility study testing a secure ED-Oncology interface for patients receiving chemotherapy who may present to unscheduled care with possible treatment-related complications. Participants are enrolled through Oncology and issued a medical-alert-style wristband with a QR code. If they attend the Emergency Department, staff can scan the QR code, access a generic study landing page, and, after SVUH authentication, complete a short structured checklist about possible serious adverse events such as infection, chest pain, vomiting, syncope, or other red-flag symptoms. The platform is designed as a secure research data-capture portal, not an electronic health record or clinical documentation system. It does not read from or write to the hospital EHR, does not provide clinical decision support, and does not change usual clinical care. Data entered by ED clinicians are limited to predefined structured fields for research and safety-signal feasibility purposes. The study will assess whether ED clinicians can complete the checklist in real time, whether the information can support earlier notification to the research/trial team, and whether this data accurately corresponds with verified serious adverse events. If feasible, Chemokeyp could help improve communication between Oncology, Emergency Medicine, and trial teams, supporting safer care for patients on chemotherapy and informing future development of ED-oncology digital safety tools.

Conditions

Serious Adverse Events; Patient Safety; Oncology; Pharmacovigilance

Outcome Measures

Primary Outcomes (1)

• Time to awareness that a patient on systemic cancer therapy attends an Emergency Department

  The goal is to see if this intervention reduces the awareness of potential serious adverse drug reactions by alerting specialist teams if someone presents to any Emergency Department for emergency care.

  Reduce time to discovery that patient has accessed Emergency Unscheduled care to a maximum of 48 hours.

Study Arms (1)

Patients receiving systemic anti-cancer therapy enrolled in the Chemokeyp feasibility study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of SVUH undergoing systemic anti-cancer therapy who may require emergent care during their cancer treatment and who consent to participate.

You may qualify if:

• Patient undergoing treatment for cancer at SVUH

You may not qualify if:

• Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation (inability to give informed consent)

Sponsors & Collaborators

• St Vincent's University Hospital, Ireland: lead

Study Sites (1)

St Vincent's University Hospital

Dublin, Dublin, D06 V8R2, Ireland

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Rosa F McNamara, FRCEM FRCPI

CONTACT

+353857111841; rosamcnamara@svhg.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 18, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

IE (1)