💬In plain words
What the trial is, and whether it could suit you
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 Seco
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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