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New treatment option for Pre-malignant
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
ClinicalTrials.gov ID: NCT06842615
What this study is testing
- What it's testing
- 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\.
- Time commitment: about 12 months
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 88. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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
- 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...
- Medication: Any treatment or activity that could impact the immune system must be considered as an exclusion criteria.These includes.
- Steroid-, chemo-, radio therapy in last 8 weeks
- Immunesuppression using following active ingredients; Methotrexate, Cyclosporine, Azathioprine, Tacrolimus, Mycophenolate, Rapamycin, Sirolimus, Mycophenolat-Mofetil in last 8 weeks.
- Granulocyte-Macrophage Colony-Stimulating Factor (GM-SCF); Molgramostim, Sargramostim in last 8 weeks o Amygdalin (Vitamin B17) in last 4 weeks
- Immune modulation using Corticosteroids, Glucocorticoids and Colchicine (Cortison/hydrocortisone \>5 mg/day, Budesonid \>5 mg/day) in last 4 weeks
- 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.
- Antibiotics and Antifungals in last 2 weeks
- Vaccination: any vaccination in last 4 weeks.
- Infection: Acute Bacterial, Viral infection and Fungal infection in last 2 weeks.
- Imaging Investigation using contrast medium in last 2 weeks.
- Dialysis on the day of blood draw.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bratislava, Slovakia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 88 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bratislava, Slovakia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.