Assessment of the analytical performance of the albumin function test in cancer screening - AFORCE-1 (Albumin FunctiOn in eaRly CancEr)

MedInnovation GmbH0 个研究点目标入组 1,965 人开始时间: 2021年7月8日最近更新: 2024年8月19日

适应症

试验速览

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•- 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

•- 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
•- 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

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