- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06834646
Comparison of 30-day Morbidity and Mortality in Cancer Patients Based on Emergency Department Location (COVER)
Comparison of 30-day Morbidity and Mortality in Cancer Patients Based on Emergency Department Location: Referring Oncology Hospital vs Other Hospitals.
Patients being followed for cancer account for 2.8% of emergency admissions in France. An acute episode that triggers a visit to the emergency department may be related to the progression of the disease, or to complications of treatment. The management of these patients is often complex and requires a degree of expertise. Emergency departments specialising in the management of cancer complications have been set up, and now deal exclusively with patients treated at their centres. However, for geographical or logistical reasons, patients with cancer are likely to consult a non-specialist emergency department and/or one located outside the cancer care centre. In this case, the emergency doctor may not have access to the oncology file, and care in the emergency department and downstream services may be sub-optimal. Studies have shown a positive impact on the quality of care and prognosis of patients thanks to the cancer centre's expertise. However, the effect of the centre on a cancer patient who visits the emergency department has never been studied. This is particularly true if the emergency department where the patient is seen is located in the cancer follow-up centre.
The primary objective of the COVER study is to investigate the impact of the location of the emergency department where the patient is seen for their prognosis.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yonathan FREUND, PU-PH
- Phone Number: 00 33 (0) 184827129
- Email: yonathan.freund@aphp.fr
Study Contact Backup
- Name: Olivier PEYRONY, MD, PhD
- Phone Number: 00 33 (0) 142494939
- Email: olivier.peyrony@aphp.fr
Study Locations
-
-
-
Paris, France, 75013
- Recruiting
- Hôpital Pitié Salpêtrière Emergency department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients aged 18 or over admitted to an emergency department with cancer that has been active or in remission for less than a year.
Exclusion Criteria:
- Opposition to participate in the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Patients who visit the ED of the refereing oncologic hospital
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Patients who visit another ED
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of days alive spent outside the hospital
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 30 days
|
30 days
|
|
|
Mortality
Time Frame: Day 90
|
Day 90
|
|
|
Occurrence of a new/ unscheduled consultation
Time Frame: 30 days
|
30 days
|
|
|
Length of hospitalisation
Time Frame: 90 day
|
90 day
|
|
|
Unscheduled consultation or hospitalization emergency department discharge
Time Frame: 7 days
|
7 days
|
|
|
Unexpected death
Time Frame: 7 days
|
7 days
|
|
|
Secondary admission to the intensive care unit during the initial hospitalization following the emergency visit
Time Frame: 7 days
|
7 days
|
|
|
Occurence of organ failure
Time Frame: 7 days
|
7 days
|
|
|
Quality of life with QLQ-C30
Time Frame: 90 days
|
QLQ-C30
|
90 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP240971
- IDRCB: 2024-A01679-38 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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