CompletedNot Applicable

NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts

United Kingdom24 participantsStarted 2022-02-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Patient adherence to protocol defined DBS time points.

Timeframe: 12 months

Number of in-home DBS samples passing quality assurance checks in patients receiving CPI therapy by multi-cytokine ELISA.

Timeframe: 12 months

Trial details

NCT IDNCT04960059

SponsorThe Christie NHS Foundation Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-30

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