Breast carcinoma, prostate carcinoma, colorectal carcinoma, lung carcinoma, urinary bladder carcinoma, non-Hodgkin's carcinoma, gastric carcinoma, renal cell carcinoma, endometrial carcinoma, pancreatic carcinoma Organ diseases of: Lung, Breast, Stomach, Pancreas, Urinary bladder, Kidney, Colon, Blood, Endometrium, Prostate gland
Conditions
Interventions
Group 1: In approximately 700 patients with therapy-naïve cancer, a blood sample is obtained once.
Group 2: In approximately 900 patients with benign diseases of the same organs as those of cancer pat
Sponsors
MedInnovation GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Group 1 - 500 patients with therapy-naïve cancer - without any cancer-naïve therapy/invasive diagnosis or inflammatory disease in the last four weeks - With any of the following cancer sites: Breast, prostate, lung, colon, uterus, stomach, urinary bladder, kidney, pancreas, or non-Hodgkin's lymphoma (NHL), respectively. - each cancer site should include approximately 50 patients with as equal a distribution of stages as possible Group 2 - 700 patients with benign diseases of the same organs as those of the cancer patients, reflecting the clinical situation in which the test is to be used (suspicious for malignancy) - for each organ at least 50 patients should be included Group 3 - 300 healthy volunteers - without any inflammatory disease in the last four weeks - without cancer or cancer therapy in the last two years - with the same age and sex distribution as in groups 1 and 2
Exclusion criteria
Exclusion criteria: (general) - Poor compliance or mental disorders - Incapacity to consent -already participating in another study in which a blood loss of blood loss of 10 ml would be harmful (patients) - Invasive diagnostics (endoscopy of: Intestine, stomach, pancreas, lungs/bronchi or any biopsy) in the last 7 days - Surgery within the last 4 weeks - Treatment with antibiotics in the last 4 weeks that are not related to the current medical reason for presentation at the clinic - Cancer or recurrence within the last 2 years - Cancer treatment (chemotherapy, radiotherapy, surgery) within the last 2 years - Vit. C infusion 24 h before blood sample was taken - and additional criteria for healthy volunteers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of DR (diagnostic result) value in both subgroups and total population of patients with malignant tumor disease (group 1) compared with healthy population (group 3) and group of patients with benign diseases (group 2, at baseline) at a cut-off of DR = 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Sensitivity and specificity of the integral discriminatory function (DR- diagnostic result) related to the data set of patients from group 2 who may still be reassigned to the group with tumor disease (group 1) after the long-term follow-up period of 12 months - the transport parameters (BE binding efficiency and DTE detoxification efficiency), expressed as the ratio of BE/DTE = 1.3 for Patients with DR values between 0.8 to 1.2. - Patients from group 1 are treated with both, patients with benign diseases (group 2), as well as with healthy subjects (group 3) compared - Subgroup analysis on patients initially not assigned to group 2 and reclassified as assigned to group 1 after 12 months | — |
Countries
Germany
Contacts
Public ContactUlrich Keilholz
Charité Comprehensive Cancer Center
Outcome results
None listed