NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts

March 17, 2026 updated by: The Christie NHS Foundation Trust
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom
        • The Christie NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare cytokine concentrations by DBS sampling and intravenous blood sampling by multi-cytokine ELISA.
Time Frame: 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.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retrospective mapping of immune-related adverse events with cytokine concentrations over time by in-home DBS sampling.
Time Frame: 12 months
The association between these statistics and the development of immune-related adverse events will be estimated using a logistic regression analysis.
12 months
Patient reported outcomes from semi-structured interviews.
Time Frame: 12 months
The patient satisfaction level will be assessed by survey interviews.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Christie NHS Foundation Trust

Collaborators

University of Manchester

Investigators

  • Principal Investigator: Donna Graham, MD, The Christie NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2022

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

July 2, 2021

First Submitted That Met QC Criteria

July 2, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTSp181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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