Skip to main content
OpenTrials
Completed

NCT Number: NCT04960059

NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Metastatic Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-small Cell Lung Cancer Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Christie NHS Foundation Trust

Manchester, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

This is an observational study

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. Patient reported outcomes from semi-structured interviews.

    Time frame: 12 months

    The patient satisfaction level will be assessed by survey interviews.

Sponsors and collaborators

Lead sponsor

The Christie NHS Foundation Trust

Other

Collaborators

  • University of Manchester

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 13, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.