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

Summary

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

Eligibility

Inclusion Criteria:

To be eligible to participate in this trial, an individual must meet all the following criteria:

Group A

* 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
* Signed informed consent
* Absence of any of exclusion criteria Group B
* 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
* 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

Conditions3

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