Assessment of the analytical performance of the albumin function test in cancer screening

Recruiting

Conditions: Breast carcinoma, prostate carcinoma, colorectal carcinoma, lung carcinoma, urinary bladder carcinoma, non-Hodgkin's carcinoma, gastric carcinoma, renal cell carcinoma, endometrial carcinoma, pancreatic carcinomaOrgan diseases of: Lung, Breast, Stomach, Pancreas, Urinary bladder, Kidney, Colon, Blood, Endometrium, Prostate gland

Registration Number: DRKS00025249

Lead Sponsor: MedInnovation GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1965

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

(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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- 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<br>- 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.<br>- Patients from group 1 are treated with both, patients with benign diseases (group 2), as well as with healthy subjects (group 3) compared<br>- Subgroup analysis on patients initially not assigned to group 2 and reclassified as assigned to group 1 after 12 months