NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts

NCT04960059 | Completed

• 1 other identifier: CFTSp181
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Renal Cell Carcinoma; Non-small Cell Lung Cancer; Metastatic Melanoma

Keywords

Immunotherapy; immune related adverse event; cytokine release

Outcome Measures

Primary Outcomes (2)

• Patient adherence to protocol defined DBS time points.

  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.

  the number of DBS samples passing quality assurance checks against the number of DBS samples successfully collected.

  12 months

Secondary Outcomes (1)

• Compare cytokine concentrations by DBS sampling and intravenous blood sampling by multi-cytokine ELISA.

  12 months

Other Outcomes (2)

• Retrospective mapping of immune-related adverse events with cytokine concentrations over time by in-home DBS sampling.

  12 months

• Patient reported outcomes from semi-structured interviews.

  12 months

Interventions

No intervention OTHER

This is an observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: collaborator
• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma.

MeSH Terms

Conditions

Neoplasms; Melanoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Donna Graham, MD

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 13, 2021
• Study Start: February 11, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)