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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

NCT06842615 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-01-16

No results posted yet for this study

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

Conditions

  • Pre-malignant
  • Malignant

Interventions

DIAGNOSTIC_TEST

Pantum detect test

epitope detection in monocyte (EDIM)

Sponsors & Collaborators

  • Comenius University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-25
Primary Completion
2027-12-31
Completion
2028-03-31

Countries

  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06842615 on ClinicalTrials.gov