The purpose of this contract is to implement a patented diagnostic test, developed within the Saint Luc University Clinics, in the framework of a clinical trial concerning patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The awardee must be available from May 15, 2026.

Description of the clinical trial:

This public procurement relates to a prospective academic phase II clinical trial in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) negative for human papillomavirus (HPV). The trial is a multicenter Belgian national study involving 10 participating centers in Belgium, coordinated by the Saint Luc University Clinics (CUSL), with UZ Gent acting as the coordination center for Flanders. The participating centers include UZ Gent, UZ Leuven, VITAZ/UZA, UZ Brussel, Jules Bordet Institute, CHU UCL Namur, Grand Hôpital de Charleroi, CHU Liège, and CHU HELORA (La Louvière, Jolimont site).

The main objective of this trial is to evaluate the clinical utility of circulating tumor DNA (ctDNA) as a biomarker for:

• molecular risk stratification;
• detection of minimal residual disease (MRD) after curative intent treatment;
• longitudinal molecular monitoring during follow-up.

Initially, all patients will undergo an evaluation of PD-L1 expression (combined positive score, CPS) and ctDNA status using a targeted next-generation sequencing (NGS) test. For patients with a PD-L1 CPS ≥20, a baseline ctDNA analysis must be performed in real-time, as the results are necessary to guide cohort allocation. All patients then receive standard curative intent chemoradiotherapy (CRT). Six to eight weeks after completion of CRT, a ctDNA analysis is repeated to assess MRD. For patients with a PD-L1 CPS ≥20 who were ctDNA positive at baseline, a post-CRT MRD ctDNA test must also be performed in real-time. For all other patients (PD-L1 CPS <20 or PD-L1 CPS ≥20 and ctDNA negative at baseline), samples are stored on-site and analyzed in batches later.

Based on the combination of PD-L1 and ctDNA results at baseline and MRD:

• patients with a PD-L1 CPS ≥20, baseline ctDNA positivity, and post-CRT MRD will integrate into an interventional cohort and benefit from intensified immunotherapy treatment;
• all other patients enter an observational cohort and receive standard follow-up.

All patients are followed for two years. During follow-up, peripheral blood samples are collected every three months. Follow-up samples are stored on-site and analyzed in batches later.

The total planned duration of the clinical trial is 4 years, including 2 years of patient recruitment followed by 2 years of clinical and molecular follow-up. The services covered by this public procurement must therefore cover the entire duration of the trial, including real-time analyses during recruitment and batch analyses during the follow-up phase.

Scope of the public contract:

The service provider must:

• perform ctDNA tests in real-time and later in batches;
• ensure tracking, sample storage;
• provide blood draw kits;
• manage logistics and coordination with the various participating centers;
• provide analysis reports and dashboards.