DRKS00025249
Recruiting
Not Applicable
Assessment of the analytical performance of the albumin function test in cancer screening - AFORCE-1 (Albumin FunctiOn in eaRly CancEr)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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
- Sponsor
- MedInnovation GmbH
- Enrollment
- 1965
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
- •\- 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
- •\- 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
- •\- 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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