Clinical trial · Observational
NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts
NCT04960059CI-TRIAL-00105931completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Patient adherence to protocol defined DBS time points.
- timeFrame
- 12 months
- description
- the number of DBS samples successfully collected against the number of total expected samples
- measure
- Number of in-home DBS samples passing quality assurance checks in patients receiving CPI therapy by multi-cytokine ELISA.
- timeFrame
- 12 months
- description
- the number of DBS samples passing quality assurance checks against the number of DBS samples successfully collected.
Secondary outcomes (1)
- measure
- Compare cytokine concentrations by DBS sampling and intravenous blood sampling by multi-cytokine ELISA.
- timeFrame
- 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.