NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts

Cancer Clinical Trial

Official title:

NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04960059
• Other study ID #: CFTSp181
• Status: Recruiting
• Start date: February 14, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2023
• Source: The Christie NHS Foundation Trust
• Contact: Donna Graham, MD
• Phone: 07881842794
• Email: donna.graham8[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Carcinoma, Renal Cell
• Metastatic Melanoma
• Non-small Cell Lung Cancer
• Renal Cell Carcinoma

Intervention

Other:
• No intervention
This is an observational study

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
The Christie NHS Foundation Trust	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Retrospective mapping of immune-related adverse events with cytokine concentrations over time by in-home DBS sampling.	The association between these statistics and the development of immune-related adverse events will be estimated using a logistic regression analysis.	12 months
Other	Patient reported outcomes from semi-structured interviews.	The patient satisfaction level will be assessed by survey interviews.	12 months
Primary	Patient adherence to protocol defined DBS time points.	the number of DBS samples successfully collected against the number of total expected samples	12 months
Primary	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	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.	12 months