Actively Recruiting
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
Led by Comenius University · Updated on 2026-01-16
134
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 88 years at inclusion
- For Group A: suspected or confirmed macroscopic solid pre-malignant or malignant lesion(s)
- For Group A: availability of FDG PET/CT result performed within 30 days before or after trial intervention
- For Group B: considered free of pre-malignant or malignant lesions at inclusion
- Willingness to undergo trial intervention
- Signed informed consent
- No exclusion criteria met
You will not qualify if you...
- Acute illness, organ transplantation, surgeries, or injuries requiring at least 8 weeks recovery (e.g., bone fracture, deep cuts, abrasions, open wounds, contusions, torn ligaments, blood in stool or urine)
- Treatment impacting immune system within last 8 weeks including steroids, chemotherapy, radiotherapy, immunosuppressants (Methotrexate, Cyclosporine, Azathioprine, Tacrolimus, Mycophenolate, Rapamycin, Sirolimus, Mycophenolat-Mofetil)
- Use of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Amygdalin (Vitamin B17), or immune modulators (Corticosteroids, Glucocorticoids, Colchicine) within specified time frames
- Use of NSAIDs and CGRP inhibitors within last 2 weeks (occasional use of Ibuprofen, Paracetamol, Aspirin allowed)
- Antibiotics or antifungals within last 2 weeks
- Vaccination within last 4 weeks
- Acute bacterial, viral, or fungal infection within last 2 weeks
- Imaging with contrast medium within last 2 weeks
- Dialysis on day of blood draw
- Genetic disorders like thrombocytopenia affecting blood cell counts
- For Group B only: previous cancer treated less than 5 years ago, ongoing cancer treatments, or newly diagnosed cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Nuclear Medicine
Bratislava, Slovakia
Actively Recruiting
Research Team
S
Soňa Balogová, prof. MD PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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