Prospective Evaluation of Diagnostic Performance of PanTum Detect Test in Adult Patients With Suspected or Confirmed Macroscopic Solid Pre-malignant or Malignant Lesion(s) Referred to Fludeoxyglucose (18F) PET/CT and in Adult Healthy Population

This prospective phase II trial aims to evaluate the diagnostic performance of multi-cancer epitope diagnosis in monocyte (EDIM) based blood test PanTum detect test for early detection of individuals with pre-malignant or malignant lesion(s). The intervention in this trial is the PanTum detect test performed in two parallel groups of participants: Group A: Adult persons * with suspected or confirmed macroscopic solid pre-malignant or malignant lesion(s) referred to FDG PET/CT * meeting the inclusion criteria and not-meeting the exclusion criteria * Expected number of participants: 67 Group B: Healthy adult persons * meeting inclusion criteria meeting the inclusion criteria and not-meeting the exclusion criteria * Expected number of participants: 67 Control method: uncontrolled Type of trial: evaluation of diagnostic performance of a diagnostic test with following Primary and Secondary objectives: Primary Objective 1\. To evaluate the sensitivity and specificity of PanTum Detect test in identification of individuals bearing macroscopic solid pre-malignant or malignant lesion(s) Secondary Objectives 1. To evaluate the positive and negative predictive value of PanTum Detect test in identification of individuals bearing macroscopic solid pre-malignant or malignant lesion(s) 2. To assess the concordance of result of PanTum Detect test with result of FDG PET/CT for macroscopic solid pre-malignant or malignant lesion(s) 3. To analyse the most frequent causes of false results of PanTum Detect test 4. To analyze the concordance rate of PanTum Detect test No1 and No2 5. To refine the interpretation criteria of PanTum Detect test 6. To analyse the subject´s willingness to participate on the trial 7. To analyse the subject´s experience with participation on the trial

NCT Number	NCT06842615
Lead Sponsor	Comenius University
Conditions	Pre-malignant, Malignant
Enrollment	134 participants
Start Date	2025-05-25
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-16