Tenders Are Invited For Laboratory Services – Selection Of A Company To Carry Out A Patented Test As Part Of A Clinical Trial Involving Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (Cetc La)

Laboratory Services – Selection Of A Company To Carry Out A Patented Test As Part Of A Clinical Trial Involving Patients With Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (Cetc La). The Purpose Of This Contract Is To Carry Out A Patented Diagnostic Test, Developed Within The Saint Luc University Clinics, As Part Of A Clinical Trial Involving Patients Suffering From Locally Advanced Squamous Cell Carcinoma Of The Head And Neck (Cetc La). The Successful Bidder Must Be Available From May 15, 2026. Description Of Clinical Trial: This Public Procurement Concerns 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). Lessai Is A Multi-Center Belgian National Study, Involving 10 Participating Centers In Belgium, Coordinated By The Cliniques Universitaire Saint-Luc (Cusl), With Uz Gent Acting As The Coordination Center For Flanders. Participating Centers 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 Tumor Dna (Ctdna) As A Biomarker For • Molecular Baseline Risk Stratification; • Detection Of Minimal Residual Disease (Mrd) After Treatment With Curative Intent; • Longitudinal Molecular Monitoring During Follow-Up. Initially, All Patients Will Undergo Assessment Of Pd-L1 Expression (Combined Positive Score, Cps) And Ctdna Status Using A Targeted Next-Generation Sequencing (Ngs) Assay. For Patients With Pd-L1 Cps ≥20, Baseline Ctdna Analysis Should Be Performed In Real-Time, As Results Are Necessary To Guide Cohort Allocation. All Patients Then Receive Standard Of Care Curative Intent Chemoradiation (Crt). Six To Eight Weeks After Completion Of Crt, Ctdna Analysis Is Repeated To Assess Mrd. For Patients With Pd-L1 Cps ≥20 Who Were Ctdna Positive At Baseline, Post-Crt Ctdna Mrd Testing Should 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 Pd-L1 Cps ≥20, Basal Ctdna Positivity And Post-Crt Mrd Enter An Interventional Cohort And Benefit From Intensification Of Treatment With Immunotherapy; • All Other Patients Enter An Observational Cohort And Benefit From 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 Analyzed In Batches Later. The Total Expected Duration Of The Clinical Trial Is 4 Years, Including 2 Years Of Patient Recruitment, Follow-Up