Serious Adverse EventsNCT07592234
Chemokeyp: A Feasibility Study for Realtime Safety Data-Capture for Potential Serious Adverse Drug Events
An observational study of Serious Adverse Events and Patient Safety, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Serious Adverse Events, Patient Safety, Pharmacovigilance
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 1 Feb 2026to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of SVUH undergoing systemic anti-cancer therapy who may require emergent care during their cancer treatment and who consent to participate.
Who may be able to join
- Patient undergoing treatment for cancer at SVUH
Who cannot join
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation (inability to give informed consent)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
St Vincent's University Hospital
Dublin, Dublin, D06 V8R2
Rosa McNamara, 00353857111841, rosamcnamara@svhg.ie
Grainne O'Kane, grainneokane@svhg.ie
About this study
Official 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.
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.
Read more
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, Pharmacovigilance, Oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving systemic anti-cancer therapy enrolled in the Chemokeyp feasibility study | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Reduce time to discovery that patient has accessed Emergency Unscheduled care to a maximum of 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Feb 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Adverse EventsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa McNamara, St Vincent's University Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592234
- Sponsor's protocol ID
- RS25-062
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07592234
- Acronym / sponsor ID
- RS25-062
- Conditions
- Serious Adverse Events, Patient Safety, Pharmacovigilance, Oncology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving systemic anti-cancer therapy enrolled in the Chemokeyp feasibility study | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of SVUH undergoing systemic anti-cancer therapy who may require emergent care during their cancer treatment and who consent to participate.
Key inclusion criteria (1 listed)
- Patient undergoing treatment for cancer at SVUH
Key exclusion criteria (1 listed)
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation (inability to give informed consent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serious Adverse Events and Patient Safety, run by St Vincent's University Hospital, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosa F McNamara, FRCEM FRCPI (+353857111841, rosamcnamara@svhg.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.