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Clinical Trials/DRKS00025249
DRKS00025249
Recruiting
Not Applicable

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

MedInnovation GmbH0 sites1,965 target enrollmentJuly 8, 2021

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.

Registry
who.int
Start Date
July 8, 2021
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

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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