Trials / Not Yet Recruiting

Not Yet RecruitingNCT07246759

Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis

NEUTROFLOW: Development and Validation of a Pan-cancer Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis of Blood Samples

Status: Not Yet Recruiting
Phase: —
Study type: Observational
Enrollment: 600 (estimated)

Sponsor: OncoHost Ltd. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The NeutroFlow study is a multi-center clinical trial designed to develop a computational model that converts flow cytometry results into a prediction of clinical benefit. The study analyzes Ly6Ehi neutrophils in biological samples from patients treated with immune checkpoint inhibitors to evaluate their likelihood of benefiting from treatment. Blood samples are collected prior to treatment and used to support the ongoing development of the algorithm.

Detailed description

The recent introduction of cancer immunotherapy based on immune checkpoint inhibitors (ICIs) has revolutionised the treatment landscape for a broad range of cancer types. However, response to ICIs varies widely between patients, with the majority experiencing resistance to therapy. Moreover, the increasing use of these costly drugs coupled with management of ICI-related toxicities creates a substantial economic burden. Current biomarker tests for determining eligibility for ICIs have limited predictive performance, and many require invasive tumour biopsies. Thus, novel (and preferentially non-invasive) biomarkers for predicting ICI clinical benefit are desperately needed for better guiding clinical decisions. NeutroFlow directly addresses this unmet need. The neutroFlow study is based on a comprehensive academic research describing a flow cytometry assay for measuring a novel predictive biomarker in the blood - Ly6Ehi neutrophil - that accurately predicts therapeutic benefit from ICIs, outperforming the approved PD-L1 biomarker. The objective of the NeutroFlow study is to develop a clinical decision-support tool that includes an antibody panel for detecting Ly6Ehi neutrophils using standard flow cytometry (FC) and a computational model that converts the FC readout into a prediction of clinical benefit. Patients will provide a single blood sample before starting treatment, and clinical data will be collected from their medical records. In the first phase of the trial, blood sample data and clinical information will be used to develop the antibody panel and train the prediction algorithm. In the second phase, the algorithm will be validated by comparing its theoretical predictions with the patients' actual objective response rates.

Conditions

Interventions

Type	Name	Description
OTHER	Blood sample collection	Blood sample collection prior treatment initiation

Timeline

Start date: 2025-11-15
Primary completion: 2027-09-30
Completion: 2028-05-30
First posted: 2025-11-24
Last updated: 2025-11-24

Locations

3 sites across 3 countries: Germany, Italy, Spain

Source: ClinicalTrials.gov record NCT07246759. Inclusion in this directory is not an endorsement.