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
Age 18-88 years at inclusion (Man, Woman)
Suspected or confirmed macroscopic solid pre-malignant or malignant lesion(s)
Availability of result of FDG PET/CT performed -30 to-15 days or up to +30 days from trial intervention and performed as a standard of care
Willingness to undergo trial intervention
Age 18-88 years at inclusion (Man, Woman)
Considered as free of pre-malignant or malignant lesion(s) at the time of inclusion
Willingness to undergo trial intervention
Signed informed consent
Parallel
Pantum detect test
Diagnostic testepitope detection in monocyte (EDIM)
PanTum test
To evaluate the sensitivity and specificity of PanTum Detect test in identification of individuals bearing macroscopic solid pre-malignant or malignant lesion(s) Localization of macroscopic solid pre-malignant or malignant lesion(s)
positive and negative predictive value of PanTum Detect test
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)
concordance of result of PanTum Detect test
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) Discordant result of PanTum Detect test and the result of FDG PET/CT for macroscopic solid pre-malignant or malignant lesion(s)
false results of PanTum Detect test
To analyse the most frequent causes of false results of PanTum Detect test
concordance rate of PanTum Detect test
To analyse the concordance rate of PanTum Detect test No1 and No2 Concordant result of PanTum Detect test No1 and No2
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