An interventional study of Pantum detect test in Pre-malignant and Malignant, sponsored by Comenius University. Recruiting at 1 site in Slovakia. Open to participants aged 18 Years to 88 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Comenius University · Not applicable, Interventional, and Diagnostic
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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
Group B:
Healthy adult persons
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
PanTum Detect is a multi-tumour screening blood test for the presence of silently growing malignant or pre-malignant lesions.
PanTum Detect is an Epitope Detection in Monocytes/Macrophages (EDIM) based test technology uses the information contained in the human immune system for detection of pre-malignant or malignant lesions. Higher than normal levels of Apo10 (DNaseX) \& transketolase-like protein 1(TKTL1) detected in macrophages of examined individuals gives an indication of potential pre-malignant or malignant lesions.
23 The test has an In Vitro Diagnostic (IVD) CE certified specificity of 99% and sensitivity of 97.5%.
For details on Intervention please refer to Appenidix 13.1 Manual-Test Kit Booklet - IFU_V04-TB-ZE-EN_DE-V4.0
In this trial, PanTum detect test is performed in two groups of participants:
In Group A of included participants:
In participants with confirmed pre-malignant or malignant lesion(s) the PanTum test is performed at the time of inclusion and its diagnostic performance will be assessed in comparison with standard of truth for fulfilment of the primary objective.
In participants with suspected pre-malignant or malignant lesion(s) the PanTum test is performed at the time of inclusion and at the end of follow-up period of 12 months and its diagnostic performance will be assessed in comparison with standard of truth for fulfilment of the primary and secondary objective. The result of PanTum Detect test performed at the end of the follow-up period will be used for fulfilment of secondary objective.
In Group B of included participants:
In healthy asymptomatic individuals at the time of inclusion and at the end of 12-month follow-up period. Its diagnostic performance at inclusion will be assessed in comparison with standard of truth.
The result of PanTum detect test at the end of follow-up period will be used for fulfilment of secondary objective.
Total duration of trial intervention for each participant is as follows:
Group A (Patients with suspected or confirmed macroscopic solid pre-malignant or malignant lesion(s) referred to FDG PET/CT): 30 days for patients with confirmed pre-malignant or malignant lesion(s) and 12 months in patients with suspected pre-malignant or malignant lesion(s) for collection of data from routine clinical workup for collection of data for standard of truth.
Reasons for duration of participation in the study:
One Pantum detect test is performed in a group of patients with confirmed pre-malignant or malignant lesion(s), at the interval of 0-30 days from FDG PET/CT, therefore the duration of inclusion for patients is 1-30 days.
However, in case of suspected malignancy and negative FDG PET/CT finding, the collection of data from routine clinical follow-up is necessary to confirm or rule-out the presence of macroscopic solid pre-malignant or malignant lesion(s) and establishment of the standard of truth.
In this group of individuals, the second PanTum detect test may be performed at the end of follow-up period to analyze the concordance of result of PanTum detect test over the time Therefore, the participation of all subjects in the study is set-up to 12 months.
Group B (Adult healthy individuals): 12 months
Reasons for duration of participation in the study: Two Pantum detect test are performed in this group:
3. one at the inclusion 24 4. and the second et the end of 12-month follow-up period
Reasons for duration of participation in the study:
When PanTum detect test is performed in this group of participants, the probability of positive finding is low however, to exclude the false negative result the non-detection of macroscopic solid pre-malignant or malignant lesion needs to be confirmed by data from routine clinical follow-up during 12 months. At the end of this follow-up period a second PanTum detect test is performed as a part of clinical follow-up to analyse the concordance of the result over the time. In case of detection of pre-malignant or malignant lesion in healthy before the end of follow-up period, the second Pantum detect test is performed at the time of its diagnosis.
Therefore, the duration of inclusion for healthy controls is 12 months.
Randomization:
The trial intervention is performed in Group A and Group B per inclusion criteria.
The blinding described below may be considered as a surrogate randomization. No other forms of randomization are applicable in this trial.
Blinding:
Method of Assignment to Trial Intervention: all included participant will receive the same intervention, as per protocol This is a single centre trial.
217 studies on the registry are indexed under Precancerous Conditions; 16 are open to participants now.
This study's planned enrollment of 134 is above the median of 70 across 143 interventional studies indexed under Precancerous Conditions.
Browse Precancerous Conditions studies →Comenius University is the lead sponsor of 42 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible to participate in this trial, an individual must meet all the following criteria:
Group A
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this trial: For Group A and B
Medication: Any treatment or activity that could impact the immune system must be considered as an exclusion criteria.These includes.
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A (Patients with suspected or confirmed macroscopic solid pre-malignant or malignant lesion(s) referred to FDG PET/CT): 30 days for patients with confirmed pre-malignant or malignant lesion(s) and 12 months in patients with suspected pre-malignant or malignant lesion(s) for collection of data from routine clinical workup for collection of data for standard of truth. Reasons for duration of participation in the study: One Pantum detect test is performed in a group of patients with confirmed pre-malignant or malignant lesion(s), at the interval of -30 to 0 or 15-30 days from FDG PET/CT, therefore the duration of inclusion for patients is 1-30 days. However, in case of suspected malignancy and negative FDG PET/CT finding, the collection of data from routine clinical follow-up is necessary to confirm or rule-out the presence of macroscopic solid pre-malignant or malignant lesion(s) and establishment of the standard of truth.
Diagnostic Test: Pantum detect test
Reasons for duration of participation in the study: Two Pantum detect test are performed in this group: 1. first at the inclusion 2. and the second et the end of 12-month follow-up period Reasons for duration of participation in the study: When PanTum detect test is performed in this group of participants, the probability of positive finding is low however, to exclude the false negative result the non-detection of macroscopic solid pre-malignant or malignant lesion needs to be confirmed by data from routine clinical follow-up during 12 months. At the end of this follow-up period a second PanTum detect test is performed as a part of clinical follow-up to analyse the concordance of the result over the time. In case of detection of pre-malignant or malignant lesion in healthy before the end of follow-up period, the second Pantum detect test is performed at the time of its diagnosis. Therefore, the duration of inclusion for healthy controls is 12 months.
Diagnostic Test: Pantum detect test
epitope detection in monocyte (EDIM)
Also known as: FDG PET/CT
PanTum test
To evaluate the sensitivity and specificity of PanTum Detect test in identification of individuals bearing macroscopic solid pre-malignant or malignant lesion(s) Localization of macroscopic solid pre-malignant or malignant lesion(s)
Time frame: 1st day
positive and negative predictive value of PanTum Detect test
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)
Time frame: 1st day
concordance of result of PanTum Detect test
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) Discordant result of PanTum Detect test and the result of FDG PET/CT for macroscopic solid pre-malignant or malignant lesion(s)
Time frame: 1st day
false results of PanTum Detect test
To analyse the most frequent causes of false results of PanTum Detect test
Time frame: 1st day
concordance rate of PanTum Detect test
To analyse the concordance rate of PanTum Detect test No1 and No2 Concordant result of PanTum Detect test No1 and No2
Time frame: 12th month
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Dec 2027, 31 months after the start.
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Comenius University