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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- PanTum test
研究概览
简要总结
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
- 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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible to participate in this trial, an individual must meet all the following criteria:
- •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
排除标准
- •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, 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
- •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
研究组 & 干预措施
Cancer Group
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.
干预措施: Pantum detect test (Diagnostic Test)
Control Group
Reasons for duration of participation in the study: Two Pantum detect test are performed in this group:
- first at the inclusion
- 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.
干预措施: Pantum detect test (Diagnostic Test)
结局指标
主要结局
PanTum test
时间窗: 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)
次要结局
- positive and negative predictive value of PanTum Detect test(1st day)
- concordance rate of PanTum Detect test(12th month)
- concordance of result of PanTum Detect test(1st day)
- false results of PanTum Detect test(1st day)