Oncology
Conditions
Brief summary
A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.
Detailed description
The study aims to enroll and obtain samples of investigational interest from 200 patients over a 36-month recruitment period. Blood and/ or stool samples will be taken at baseline, in context of irAE development / during CPI treatment and during follow-up. Skin samples may also be taken upon development of organspeciifc irAEs. Further assessments at baseline or during the course of or following treatment will be conducted in accordance with standard institutional practice and will be clinically driven. Clinical data, samples and results from archival, current or prospective diagnostic or therapeutic procedures will be used for research purposes within EXACT. IrAE clinical monitoring will be conducted in accordance with standard institutional practice and will be clinically driven.
Interventions
None listed
Sponsors
Royal Marsden NHS Foundation Trust
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Age 18 years or older * Confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy
Exclusion criteria
* Medical or psychological condition that would preclude informed consent * Planned participation in a drug trial receiving investigational agents * Subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry. * Subjects unable to comply with the study or sample schedule.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients who experience irAEs | 36 months | To determine the proportion of patients who experience irAEs during treatment with CPI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological and clinical characteristics | 60 months | To profile biological and clinical characteristics at baseline and during treatment with CPI to detect indicators predictive of the development of immunotherapy-related adverse events (irAEs). |
| Time to development of irAEs | 36 months | To determine time to clinical development of irAEs during treatment with CPI. |
| Proportion of patients experiencing irAEs | 60 months | • To determine the proportion of patients experiencing any irAE during long-term follow up, post treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Impact on patients quality of life using patient questionnaires | 60 months | • Explore the quality-of-life impact on patients enrolled in longitudinal multi-facet disease profiling and in patients who develop irAEs. |
Countries
United Kingdom
Contacts
Primary ContactLaura Boddy
Backup ContactArjun Modi
Outcome results
None listed