Pre-malignantPanTumPETNCT06842615
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
A study testing Pantum detect test in people with Pre-malignant and Malignant, run by Comenius University at 1 site in Slovakia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-malignant, Malignant
- What is being tested?
- Pantum detect test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSlovakia
- Study dates
- 25 May 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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, contusion, torn ligaments, blood in the stool, blood in the urine. After successful recovery the waiting period must be 8 weeks.
- 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
Show all 16Show fewer
- 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 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine
Bratislava
Sona Balogova, prof. MD PhD., +421 2 59 77 72 90, sona.balogova@fmed.uniba.sk
Sona Balogova, prof. MD PhD.
About this study
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:
Read more
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
- 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
- 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)
- 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)
- To analyse the most frequent causes of false results of PanTum Detect test
- To analyze the concordance rate of PanTum Detect test No1 and No2
- To refine the interpretation criteria of PanTum Detect test
- To analyse the subject´s willingness to participate on the trial
- To analyse the subject´s experience with participation on the trial
Read the detailed description
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:
- 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:
- The laboratory performing the Pantum detect test is blinded to clinical context of the participant with corresponding blood sample.
- The independent assessor is blinded to result of PanTum detect test for establishment of the standard of truth No within-trial transition is possible in tris trial As this is the trial with diagnostic test the dose escalation or dose-ranging is not applicable.
Method of Assignment to Trial Intervention: all included participant will receive the same intervention, as per protocol This is a single centre trial.
- Conditions
- Pre-malignant, Malignant
- Being tested
- Pantum detect test
- Keywords
- macroscopic, solid lesion, pre-malignant, malignant lesion
- Medical subject headings
- Precancerous Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pantum detect testDiagnostic test
Also called FDG PET/CT
epitope detection in monocyte (EDIM)
| Study group | Role | What they receive |
|---|---|---|
| Cancer Group | Experimental | 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. Receives: Diagnostic Test: Pantum detect test |
| Control Group | Other | 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. Receives: Diagnostic Test: Pantum detect test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1st day
Secondary outcomes (4)
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)
Measured: 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)
Measured: 1st day
false results of PanTum Detect test
To analyse the most frequent causes of false results of PanTum Detect test
Measured: 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
Measured: 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start25 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-malignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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. The test has an In Vitro Diagnostic (IVD) CE certified specificity of 99% and sensitivity of 97.5%.
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842615
- Sponsor's protocol ID
- VEGA 1/0394/24
- Other IDs
- 2024-514272-40-00
- Acronym
- PanTumPET
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- PanTumPET / VEGA 1/0394/24
- Conditions
- Pre-malignant, Malignant
- Keywords
- macroscopic, solid lesion, pre-malignant, malignant lesion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 25 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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)
- 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)
- To analyse the most frequent causes of false results of PanTum Detect test
- To analyze the concordance rate of PanTum Detect test No1 and No2
- To refine the interpretation criteria of PanTum Detect test
- To analyse the subject´s willingness to participate on the trial
- To analyse the subject´s experience with participation on the trial
Detailed description
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:
- 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:
- The laboratory performing the Pantum detect test is blinded to clinical context of the participant with corresponding blood sample.
- The independent assessor is blinded to result of PanTum detect test for establishment of the standard of truth No within-trial transition is possible in tris trial As this is the trial with diagnostic test the dose escalation or dose-ranging is not applicable.
Method of Assignment to Trial Intervention: all included participant will receive the same intervention, as per protocol This is a single centre trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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. The test has an In Vitro Diagnostic (IVD) CE certified specificity of 99% and sensitivity of 97.5%.
| Arm | Type | Receives |
|---|---|---|
| Cancer Group | Experimental | Diagnostic Test: Pantum detect testGroup 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. |
| Control Group | Other | Diagnostic Test: Pantum detect testReasons 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. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (16 listed)
- 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, contusion, torn ligaments, blood in the stool, blood in the urine. After successful recovery the waiting period must be 8 weeks.
- Medication: Any treatment or activity that could impact the immune system must be considered as an exclusion criteria.These includes.
- Vaccination: any vaccination in last 4 weeks.
- Infection: Acute Bacterial, Viral infection and Fungal infection in last 2 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pantum detect testAlso: FDG PET/CTepitope detection in monocyte (EDIM) | Diagnostic test | Cancer Group, Control Group |
Primary outcome
PanTum test
Time frame: 1st day
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)
4 secondary outcomes
positive and negative predictive value of PanTum Detect test
Time frame: 1st day
concordance of result of PanTum Detect test
Time frame: 1st day
false results of PanTum Detect test
Time frame: 1st day
concordance rate of PanTum Detect test
Time frame: 12th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pantum detect test in people with Pre-malignant and Malignant, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soňa Balogová, prof. MD PhD. (+421 2 59 77 72 90, sona.balogova@fmed.uniba.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PanTum test (time frame: 1st day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.