NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts

Recruiting

• Conditions: Metastatic Melanoma; Renal Cell Carcinoma; Cancer; Non-small Cell Lung Cancer

• Registration Number: NCT04960059
• Lead Sponsor: The Christie NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-02
• Study First Posted: 2021-07-13
• Study Start: 2022-02-14
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12
• Primary Completion: 2023-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient adherence to protocol defined DBS time points.	12 months	the number of DBS samples successfully collected against the number of total expected samples
Number of in-home DBS samples passing quality assurance checks in patients receiving CPI therapy by multi-cytokine ELISA.	12 months	the number of DBS samples passing quality assurance checks against the number of DBS samples successfully collected.

Secondary Outcome Measures

Name	Time	Method
Compare cytokine concentrations by DBS sampling and intravenous blood sampling by multi-cytokine ELISA.	12 months	The changes of cytokine concentrations will be estimated by the log-ratio of cytokine concentrations measured at two time points. The trend of cytokine concentration during treatment will be estimated by fitting a linear regression model based on all cytokine concentrations collected during treatment.

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom