Belgium – Laboratory services – Sélection d’une entreprise pour la réalisation d’un test breveté dans le cadre d’un essai clinique portant sur des patients atteints de carcinome épidermoïde de la tête et du cou localement avancé (CETC LA)

The present contract concerns the implementation of a patented diagnostic test, developed within the Cliniques universitaires Saint Luc, as part of a clinical trial involving patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The successful tenderer must be available from 15 May 2026. Description of the clinical trial: This public contract concerns an academic phase II prospective clinical trial in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who are negative for human papillomavirus (HPV). The trial is a national, multicentre study in Belgium, involving 10 participating centres in Belgium, coordinated by the Cliniques universitaires Saint-Luc (CUSL), with UZ Gent acting as the coordination centre for Flanders. The participating centres include UZ Gent, UZ Leuven, VITAZ/UZA, UZ Brussel, Institut Jules Bordet, CHU UCL Namur, Grand Hôpital de Charleroi, CHU Liège and CHU HELORA (La Louvière, Site Jolimont). The primary objective of this trial is to evaluate the clinical utility of circulating tumour DNA (ctDNA) as a biomarker for • molecular risk stratification at baseline; • detection of minimal residual disease (MRD) after curative-intent treatment; • longitudinal molecular surveillance 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-of-care 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 positive for ctDNA 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 baseline ctDNA negative), samples are stored on-site and analysed in batches later. Based on the combination of baseline PD-L1 and ctDNA results and MRD: • patients with a PD-L1 CPS ≥20, baseline ctDNA positivity, and post-CRT MRD enter an intervention cohort and receive treatment intensification with immunotherapy; • 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 taken every three months. Follow-up samples are stored on-site and analysed 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 contract 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 in batches later; - ensure sample follow-up and storage; - provide blood collection kits; - manage logistics and coordination with the different participating centres; - provide analysis reports and dashboards.