Pancreatic cancer diagnostic
AssigneeFred Hutchinson Cancer Research Center
InventorsPaul Lampe, Sunil R. Hingorani
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Abstract
The present disclosure provides methods of using certain biomarker expression profiles in the detection, diagnosis, prognosis, or development of treatment regimens for various cellular hyperproliferative disorders of the pancreas. For example, methods comprise detecting whether the concentration of ERBB2, ESR1, and TNC in a test biological sample from a subject is elevated as compared to a control.
Claims53
A method for detecting the risk of a pancreas hyperproliferative disorder (PHD), comprising identifying the risk of the PHD in a human subject when a test sample from the human subject has at least one biomarker antigen that is elevated compared to a control,
- wherein the level of biomarker antigen in the sample is measured by detecting the amount of biomarker antigen in the sample that specifically binds to an antigen binding domain;
- and
- the biomarker antigen comprises at least one of an ERBB2 antigen, an ESR1 antigen, a TNC antigen, or any combination thereof.
A method for diagnosing a pancreas hyperproliferative disorder (PHD), comprising diagnosing the PHD in a human subject when a test sample from the human subject has at least one biomarker antigen that is elevated compared to a control,
- wherein the level of biomarker antigen in the sample is measured by detecting the amount of biomarker antigen in the sample that specifically binds to an antigen binding domain;
- and
- the biomarker antigen comprises at least one of an ERBB2 antigen, an ESR1 antigen, a TNC antigen, or any combination thereof.
A method of identifying a human subject in need of additional screening for a pancreatic hyperproliferative disorder (PHD), comprising identifying the human subject when a test sample from the human subject has at least one biomarker antigen that is elevated compared to a control,
- wherein the level of biomarker antigen in the sample is measured by detecting the amount of biomarker antigen in the sample that specifically binds to an antigen binding domain;
- the biomarker antigen comprises at least one of an ERBB2 antigen, an ESR1 antigen, a TNC antigen, or any combination thereof, and
- the additional screening comprises at least one of endoscopic ultrasound, computed tomography, magnetic resonance imaging, and biopsy.
A method of monitoring progression, residual disease, or recurrence of a pancreas hyperproliferative disorder (PHD) in a human subject, comprising detecting the level of at least one biomarker antigen in a sample from a human subject that has received at least one treatment for the PHD and comparing the expression of the biomarker antigen to a control,
- wherein the level of biomarker antigen in the sample is measured by detecting the amount of biomarker antigen in the sample that specifically binds to an antigen binding domain;
- and
- the biomarker antigen comprises at least one of an ERBB2 antigen, an ESR1 antigen, a TNC antigen, or any combination thereof.
A method of evaluating the efficacy of a pancreas hyperproliferative disorder (PHD) therapy in a human subject comprising administering a PHD therapy to a human subject and determining the efficacy of the therapy by measuring the level of at least one biomarker antigen compared to a control,
- wherein the level of biomarker antigen in the sample is measured by detecting the amount of biomarker antigen in the sample that specifically binds to an antigen binding domain;
- and
- the biomarker antigen comprises at least one of an ERBB2 antigen, an ESR1 antigen, a TNC antigen, or any combination thereof.
The method of any one of the preceding claims, wherein the biomarker antigens comprise an ERBB2 antigen, an ESR1 antigen, and a TNC antigen.
The method of claim any one of the preceding claims, wherein at least 2 or at least 3 of the biomarker antigens in the sample are elevated.
The method according to any one of the preceding claims, further comprising detecting the level of a CA19-9 antigen.
The method of any one of the preceding claims, wherein the level of expression of the biomarker antigen is at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, or 20 fold higher than the control.
The method according to any one of the preceding claims, wherein the antigen binding domain is detected with a labeled anti-human immunoglobulin.
The method of any of the preceding claims, further comprising the step of performing a endoscopic ultrasound, computed tomography, magnetic resonance imaging, or biopsy on the human subject to confirm the presence of a pancreatic cancer.
A method for treating a pancreas hyperproliferative disorder (PHD), comprising administering to a human subject an effective therapeutic regimen for a human subject wherein the PHD is detected in the subject identified when a test sample from the human subject has at least one biomarker antigen that is elevated compared to a control,
- wherein the level of biomarker antigen in the sample is measured by detecting the amount of biomarker antigen in the sample that specifically binds to an antigen binding domain;
- and
- the biomarker antigen comprises at least one of an ERBB2 antigen, an ESR1 antigen, a TNC antigen, or any combination thereof.
The method of any one of the preceding claims, wherein the human subject is at high risk for developing a PHD.
The method of any one of the preceding claims, wherein the biological sample is blood.
The method of any one of the preceding claims, wherein the biological sample is plasma.
The method of any one of the preceding claims, wherein specificity for PDA is at least about 90% and sensitivity is at least about 30%.
The method of any one of the preceding claims, wherein the level of a further biomarker antigen is measured, wherein the further biomarker antigen is selected from CA19-9 antigen, SEPT5, IL2RA, KRT16, GATA3, TLX3, CDK2AP1, STAT3, CLU, SERPINH1, HOXD13, BCL2, IL1A, MLLT10, DDB2, CD20, BRAF, STEAP2, PKM2, NDRG1, or any combination thereof.
Dependencies are inferred from the claim text.