CancerNCT04960059
NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts
An observational study of Cancer and Metastatic Melanoma, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Metastatic Melanoma, Renal Cell Carcinoma
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Feb 2022to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- No intervention
- Keywords
- Immunotherapy, immune related adverse event, cytokine release
- Medical subject headings
- Neoplasms, Melanoma, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient adherence to protocol defined DBS time points.
the number of DBS samples successfully collected against the number of total expected samples
Measured: 12 months
Number of in-home DBS samples passing quality assurance checks in patients receiving CPI therapy by multi-cytokine ELISA.
the number of DBS samples passing quality assurance checks against the number of DBS samples successfully collected.
Measured: 12 months
Secondary outcomes (1)
Compare cytokine concentrations by DBS sampling and intravenous blood sampling by multi-cytokine ELISA.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start11 Feb 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Donna Graham, MD, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960059
- Sponsor's protocol ID
- CFTSp181
- Status last verified
- Mar 2026
- First submitted
- 2 Jul 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts
- ClinicalTrials.gov ID
- NCT04960059
- Acronym / sponsor ID
- CFTSp181
- Keywords
- Immunotherapy, immune related adverse event, cytokine release
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 13 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study | Other | – |
Primary outcome
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
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.
1 secondary outcome
Compare cytokine concentrations by DBS sampling and intravenous blood sampling by multi-cytokine ELISA.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Graham, MD principal investigator
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Metastatic Melanoma, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient adherence to protocol defined DBS time points. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.