Clinical trial NCT04960059: NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts
Official title: NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Metastatic Melanoma
Renal Cell Carcinoma
Non-small Cell Lung Cancer
Keywords: Immunotherapy
immune related adverse event
cytokine release
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2021-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving checkpoint inhibitor therapy as first line treatment of renal cell carcinoma, metastatic melanoma or non-small cell lung cancer (in combination with chemotherapy for NSCLC).

Brief summary: This study will explore the ability of patients on first line combination immunotherapy to sample cytokines at home. The data from this study will be used to evaluate the feasibility of in-home testing and the ability to analyse patients cytokine profiles retrospectively to help feed the development of further studies.

Detailed description: Patients will be informed of the study and given a minimum of 24 hours to consider. Once consented patients will enter the study where they will take cytokine samples at home over a 12 week period.

Eligibility criteria: Inclusion Criteria:

* Voluntary informed consent.
* Aged at least 18 years.
* Diagnosis of locally advanced or metastatic RCC, Melanoma or NSCLC
* In the opinion of the investigator deemed suitable to receive first-line combination immunotherapy (RCC and MM) or combination immunotherapy and chemotherapy (NSCLC).
* Willingness to comply with scheduled trial procedures.
* Capable of performing own dry blood sampling procedure, or a carer who is willing and able to perform them.

Exclusion Criteria:

* Previous immunotherapy (including any CPI either as single agent on in combination, or high dose interleukin-2).
* Judgement by the investigator that the individual should not participate if they are unlikely to comply with study procedures and requirements.
* Patients receiving long term oral anticoagulation deemed by the clinician to be at risk from daily finger pricking.

Primary outcomes:
measure: Patient adherence to protocol defined DBS time points.
timeFrame: 12 months
measure: Number of in-home DBS samples passing quality assurance checks in patients receiving CPI therapy by multi-cytokine ELISA.
timeFrame: 12 months
Secondary outcomes:
measure: Compare cytokine concentrations by DBS sampling and intravenous blood sampling by multi-cytokine ELISA.
timeFrame: 12 months
Other outcomes:
measure: Retrospective mapping of immune-related adverse events with cytokine concentrations over time by in-home DBS sampling.
timeFrame: 12 months
measure: Patient reported outcomes from semi-structured interviews.
timeFrame: 12 months
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Donna Graham, MD
role: PRINCIPAL_INVESTIGATOR
References: