Status:
COMPLETED
ePRIME: Patient-Reported AEs in Early Phase Trials
Lead Sponsor:
University of Leeds
Collaborating Sponsors:
Yorkshire Cancer Research
The Leeds Teaching Hospitals NHS Trust
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Brief Summary
New treatments are continually being developed to help patients living with advanced cancer, which require extensive clinical trials before authorisation for standard clinical use. Reporting of advers...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Cancer patients enrolled in an academic Phase I or Phase II EPCT;
- Patients receiving novel anticancer agents, including but not limited to novel agents, such as chemotherapy, targeted agents, or chemo-radiotherapy, chemo-immunotherapy ;
- Within 1 month of having started treatment on an early phase clinical trial;
- Able and willing to give informed consent;
- Able to read and understand English;
- Access to internet via a computer, laptop, tablet or mobile phone;
- Aged ≥ 18.
- Exclusion Criteria
- Patients involved in an EPCT involving surgery or radiotherapy alone;
- Patients involved in commercial EPCTs
- Patients who will be on an early phase clinical trial for less than 3 months;
- Evidence of overt psychopathology or serious cognitive dysfunction which would impede study participation.
Exclusion
Key Trial Info
Start Date :
August 9 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03461939
Start Date
August 9 2018
End Date
August 31 2021
Last Update
September 29 2021
Active Locations (2)
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1
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS9 7TF
2
Weston Park Hospital
Sheffield, United Kingdom