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 range

18 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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