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NCT Number: NCT07592234

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient undergoing treatment for cancer at SVUH

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rosa F McNamara, FRCEM FRCPI

CONTACT

[email protected]

+353857111841

Sponsors and collaborators

Lead sponsor

St Vincent's University Hospital, Ireland

Other

Registry information

Official study title

Chemokeyp: A Feasibility Study to Evaluate and Further Develop Patient Safety Software Enabling Efficient and Effective Information Exchange for Patients Undergoing Systemic Cancer Treatment Who Access Emergency or Unscheduled Care.

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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