University of California

Hvidovre Hospital

Rigshospitalet

Herlev Hospital

Julia S Johansen

Paul A Price

Ib Jarle Christensen

Hans Jørgen Nielsen

Børge Grønne Nordestgaard

Stig Bojesen

Nicolai Aagaard Schultz

Benny Vittrup Jensen

The present invention relates to methods of diagnosing the presence of a non-specific disease or disorder in a subject, wherein a determined level of YKL-40 above a reference level indicates the presence of a non-specific disease or disorder. The subject may suffer from a variety of diseases or disorders. The reference level may be a reference level obtained from healthy individuals or it may be a previous measurement obtained from the same subject. The present invention furthermore relates to a method for classifying the severity of a non-specific disease or disorder in a subject, wherein a determined level of YKL-40 above or below one or more reference levels gives the severity of said non-specific disease or disorder. The present invention further relates to a kit and a device that may be used in the method of the present invention comprising means for measuring the level of YKL-40 in a sample; and means for comparing the measured level of YKL-40 with at least one reference level of YKL-40.

YKL-40 as a general marker for non-specific disease

The present invention relates to gastrointestinal cancers and methods for selecting a treatment for said gastrointestinal cancer in a subject. The present invention further relates to a methods of diagnosing the presence of and/or classifying the severity of a gastrointestinal cancer; together with methods for determining the effect of a therapy administered and/or the prognosis for a subject suffering from a gastrointestinal cancer, before, during or after administering the treatment. For all the methods applies that a determined level of YKL-40 above one or more reference levels indicates the treatment, the severity of the disease, the effect of the treatment and/or the prognosis of the subject. The reference level is typically a level obtained from healthy individuals or a level previously obtained from the same subject. The subject may suffer from any one or more gastrointestinal cancers, such as upper gastrointestinal cancers, and metastatic colorectal cancer. The present invention further relates to a kit and a device that may be used in the method of the present invention.

YKL-40 as a marker for gastrointestinal cancers

This invention provides methods for detecting cancers and for evaluating the prognosis of cancer patients. In particular, the methods of this invention utilize YKL-40 as a marker for the presence or absence of a cancer and for the prognosis (e.g. likelihood of recurrence) of a cancer. Elevated levels of YKL-40 are indicative of the presence of a cancer in undiagnosed subjects and indicate likely recurrence of the cancer in subjects diagnosed as having a cancer.

YKL-40 as a marker and prognostic indicator for cancers

The invention is a method of identifying the presence of a disease state in a mammal which is associated with degradation of connective tissue in the mammal which contains the protein known as YKL-40. The method is a competitive immunoassay for YKL-40. It can be used, for example, to identify the presence of inflammatory or degenerative joint disease and tumor metastasis (to the extent it can be correlated to serum YKL-40 levels). Serum YKL-40 levels as detected and quantified by the inventive method are also suggestive of the prognosis for the length of survival in breast cancer patients following recurrence and/or metastasis of their cancers.

Assay for YKL-40 as a marker for degradation of mammalian connective tissue matrices

The invention is a method of identifying the presence of, and monitoring, a disease state in a mammal which is associated with degradation of connective tissue in the mammal. The method detects and determines whether diagnostically or prognostically significant levels of YKL-40 protein and/or YKL-40 peptide are present in a biological sample. The method can be used, for example, to identify the presence of inflammatory joint disease or degeneration of connective tissue in organs. Serum YKL-40 levels as detected and quantified by the invention method are also suggestive of the prognosis for the length of survival in breast cancer patients following recurrence and/or metastasis of their cancers.

This invention is a method of identifying the presence of, and monitoring, a disease state in a mammal which is associated with degradation of connective tissue in the mammal. The method detects and determines whether diagnostically or prognostically significant levels of YKL-40 protein and/or YKL-40 peptide are present in a biological sample. The method can be used, for example, to identify the presence of inflammatory or degenerative joint disease or degeneration of connective tissue in organs. Serum YKL-40 levels as detected and quantified by the inventive method are also suggestive of the prognosis for the length of survival in breast cancer patients following recurrence and/or metastasis of their cancers. The figure shows the elution position of substantially pure serum YKL-40 on a gel filtration column.

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Copenhagen, Denmark

Julia S Johansen