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

Launched by COMENIUS UNIVERSITY · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new blood test called the PanTum Detect test, which aims to help detect early signs of serious conditions like pre-malignant or malignant lesions (which can be potential cancer) in adults. The trial will involve two groups of participants: one group with suspected or confirmed lesions who are already undergoing a specific imaging test called FDG PET/CT, and another group of healthy adults who do not have any known lesions. Both groups will have around 67 participants, aged between 50 and 65 years.

To join this trial, participants in Group A must have a suspected or confirmed lesion and be willing to undergo the blood test. Those in Group B should be healthy with no history of lesions or cancer. Participants will be asked to sign an informed consent form, meaning they understand what the trial involves. Throughout the trial, researchers will assess how well the PanTum Detect test works compared to the FDG PET/CT imaging. They will also look at how many correct and incorrect results the test produces to improve its accuracy. This trial is not yet recruiting participants, but it aims to gather important data that could help in the early detection of cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• To be eligible to participate in this trial, an individual must meet all the following criteria:
• • Group A
• • Age 50-65 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
• • Signed informed consent
• • Absence of any of exclusion criteria Group B
• • Age 50-65 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
• • Absence of any of exclusion criteria
• Exclusion Criteria:
• • An individual who meets any of the following criteria will be excluded from participation in this trial: For Group A and B
• • 1. Acute Illness, Organ Transplantation, Surgeries, and injuries are an exclusion criteria: e.g. bone fracture, deep cut (deeper 0.5 cm and/or larger than 1 cm), abrasion (greater than 5 cm in diameter), open wound, contusion, torn ligaments, blood in the stool, blood in the urine. After successful recovery the waiting period must be 8 weeks.
• • 2. Medication: Any treatment or activity that could impact the immune system must be considered as an exclusion criteria.These includes.
• • 1. Steroid-, chemo-, radio therapy in last 8 weeks
• • 2. Immunesuppression using following active ingredients; Methotrexate, Cyclosporine, Azathioprine, Tacrolimus, Mycophenolate, Rapamycin, Sirolimus, Mycophenolat-Mofetil in last 8 weeks.
• • 3. Granulocyte-Macrophage Colony-Stimulating Factor (GM-SCF); Molgramostim, Sargramostim in last 8 weeks o Amygdalin (Vitamin B17) in last 4 weeks
• • 4. Immune modulation using Corticosteroids, Glucocorticoids and Colchicine (Cortison/hydrocortisone \>5 mg/day, Budesonid \>5 mg/day) in last 4 weeks
• • 5. Non-Steroidal anti-inflammatory drugs (NSAIDs) \& CGRP including in last 2 weeks. An occasional use of Ibuprofen, Paracetamol and Aspirin is not an exclusion criteria.
• • 6. Antibiotics and Antifungals in last 2 weeks
• • 3. Vaccination: any vaccination in last 4 weeks.
• • 4. Infection: Acute Bacterial, Viral infection and Fungal infection in last 2 weeks.
• • 5. Imaging Investigation using contrast medium in last 2 weeks.
• • 6. Dialysis on the day of blood draw.
• • 7. Genetic disorder such as thrombocytopenia may leads to rejection of test due to reduced amount of Blood Cells.
• For Group B only:
• • 1. Previous and Current Cancer: In case of previously diagnosed and successfully treated Tumour \& cancer, the PanTum Detect test should be done 5 years after the successful treatment \& cure. This applies to all kind of Tumour and Cancers. all currently ongoing cancer treatments and newly diagnosed cancer including ongoing diagnostic procedures are an exclusion criterion