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AssigneesHerlev Hospital, Rigshospitalet, Hvidovre Hospital
InventorsJulia Sidenius Johansen, Nicolai Aagaard Schultz, Benny Vittrup Jensen, Stig Bojesen, Børge Grønne Nordestgaard, Hans Jørgen Nielsen, Ib Jarle Christensen
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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.
A method for determining a therapy for a gastrointestinal cancer in a subject, said method comprising:
The method according to any of the preceding claims, wherein the method is a method for determining a therapy for a gastrointestinal cancer in a subject, said method comprising:
The method according to any of the preceding claims, wherein the one or more reference levels of YKL-40 is one or more age adjusted reference levels obtained by measuring the YKL-40 level in samples from healthy individuals.
The method according to any of the preceding claims, wherein one of the one or more reference levels of YKL-40 is an age adjusted cut-off value corresponding to the 70th percentile of serum or plasma YKL-40 levels in healthy individuals.
The method according to any of the preceding claims, wherein one of the one or more reference levels of YKL-40 is an age adjusted cut-off value corresponding to the 75th percentile of serum or plasma YKL-40 levels in healthy individuals.
The method according to any of the preceding claims, wherein the reference level of YKL-40 is an age adjusted cut-off value corresponding to the 85th percentile of serum or plasma YKL-40 levels in healthy individuals.
The method according to any of the preceding claims, wherein one of the one or more reference levels of YKL-40 is an age adjusted cut-off value corresponding to the 90th percentile of serum or plasma YKL-40 levels in healthy individuals.
The method according to any of the preceding claims, wherein the reference level of YKL-40 is an age adjusted cut-off value corresponding to the 95th percentile of serum or plasma YKL-40 levels in healthy individuals.
The method according to any of the preceding claims, wherein one of the one or more reference levels of YKL-40 is an age adjusted cut-off value corresponding to the 97.5th percentile of serum or plasma YKL-40 levels in healthy individuals.
The method according to any of the preceding claims, wherein the one or more reference levels of YKL-40 is a set of YKL-40 age dependent reference levels obtained by measuring the YKL-40 levels in samples from age distributed subpopulations of healthy individuals.
The method according to any of the preceding claims, wherein the determination in step i) is performed prior to initiation of the treatment in question.
A method for determining the effect of a therapy for a gastrointestinal cancer in a subject, said method comprising:
A method for determining a prognosis for a subject suffering from an upper gastrointestinal cancer and being treated with a therapeutic treatment selected from the group consisting of chemotherapeutic agents, biological agents, radiotherapy, and combinations thereof, said method comprising
A method for monitoring therapeutic treatments selected from the group consisting of chemotherapeutic agents, biological agents, radiotherapy, and combinations thereof, of an upper gastrointestinal cancer in a subject, said subject being treated for the specific disease, said method comprising
A method for diagnosing the presence of a gastrointestinal cancer in a subject, said method comprising
A method for classifying the severity of a gastrointestinal cancer in a subject, said method comprising
The method according to any of the preceding claims, wherein the gastrointestinal cancer is an upper GI cancer.
The method according to any of the preceding claims, wherein the gastrointestinal cancer is one or more upper GI cancers selected from the group consisting of esophageal cancer, gastric/stomach cancer, pancreatic cancer and biliary cancer.
The method according to any of the preceding claims, wherein the gastrointestinal cancer is pancreatic cancer.
The method according to any of the preceding claims, wherein a monitoring is performed in conjunction with a treatment of the gastrointestinal cancer.
The method according to any of the preceding claims, wherein the treatment is surgery, and/or treatment with chemotherapeutic and/or biological agents and/or radiotherapy.
The method according to any of the preceding claims, wherein the treatment is selected from the group consisting of chemotherapeutic agents, biological agents, radiotherapy and combinations thereof.
The method according to any of the preceding claims, wherein the chemotherapeutic treatment comprises the administration of one or more of the compounds selected from the group consisting of fluorouracil, capecitabine, irinotecan, oxaliplatin, gemcitabin, docetaxel, erlotinib, and leucovorin.
The method according to any of the preceding claims, wherein the treatment comprises one or more agents selected from the group consisting of biologic agents and chemotherapeutic agents.
The method according to any of the preceding claims, wherein the treatment comprises biologic agents, such as EGFR inhibitors or VEGF inhibitors.
The method according to any of the preceding claims, wherein the treatment comprises EGFR inhibitors;
The method according to any of the preceding claims, wherein the treatment comprises Cetuximab.
The method according to any of the preceding claims, wherein the YKL-40 level is determined using an immunoassay.
The method according to any of the preceding claims, wherein the YKL-40 level is determined in a PCR based assay.
The method according to any of the preceding claims, wherein the level of one or more additional biomarkers are determined in the same sample as the YKL-40 level.
The method according to any of the preceding claims, wherein the YKL-40 level is determined by use of a dipstick.
The method according to any of the preceding claims, wherein the biological sample is blood, serum, or plasma.
The method according to any of the preceding claims, wherein the biological sample is serum or plasma.
The method according to any of the preceding claims, wherein the subject is a mammal, preferably a human.
A device for determining a therapy for and/or monitoring a therapeutic treatment of a gastrointestinal cancer in a subject, wherein the device comprises means for measuring the level of YKL-40 in a sample;
The device according to 79, wherein the device comprises means for comparing the measured level of YKL-40 with a set of age dependent reference levels as defined in the following table:
A kit of parts comprising
Dependencies are inferred from the claim text.