Methods for the early detection of lung cancer
OwnerBarry L. Dowell, Philip M. Hemkeninventors
Life of this patent
Estimating the term…
Abstract
Provided are methods of diagnosing lung cancer, particularly at an early stage, such as stage I, by detecting the presence and/or amount of at least four biomarkers of lung cancer in a sample from a subject as well as determining the number of smoking pack years for the subject. The methods and biomarkers may be used to develop an accurate prognosis for a patient having lung cancer or suspected of having lung cancer or accurately diagnose a subject having or suspected of having lung cancer. The methods and biomarkers may be used to identify and/or classify a patient as a candidate for lung cancer treatment therapy.
Claims50
A method for identifying and treating a subject having or at risk of having lung cancer, the method comprising the steps of:
- a. obtaining a biological sample from a subject;
- b. determining the levels of midkine (MK), tissue factor pathway inhibitor (TFPI), neuron-specific enolase (NSE) and carbohydrate antigen 19-9 (CA19-9) in the biological sample from the subject;
- c. determining the number of pack years of smoking of the subject;
- d. comparing the levels of MK, TFPI, NSE and CA19-9 in the biological sample to reference levels of MK, TFPI, NSE and CA19-9;
- e. comparing the number of pack years of smoking by the subject to a reference level of pack years;
- f. identifying the subject as having lung cancer or at risk of having lung cancer if the levels of MK, TFPI, NSE and CA19-9 in the biological sample are greater than the reference levels of MK, TFPI, NSE and CA19-9 and the number of pack years of smoking by the subject is greater than the reference level of pack years;
- and
- g. administering a lung cancer treatment regimen to the subject identified as having lung cancer or a lung monitoring regimen to the subject identified as at risk of having lung cancer.
A method of providing a diagnosis of a subject having lung cancer, the method comprising the steps of:
- a. obtaining a biological sample from a subject;
- b. determining the levels of midkine (MK), tissue factor pathway inhibitor (TFPI), neuron-specific enolase (NSE) and carbohydrate antigen 19-9 (CA19-9) in the biological sample from the subject;
- c. determining the number of pack years of smoking of the subject;
- d. comparing the levels of MK, TFPI, NSE and CA19-9 in the biological sample to reference levels of MK, TFPI, NSE and CA19-9;
- e. comparing the number of pack years of smoking by the subject to a reference level of pack years;
- and
- f. providing a diagnosis of a subject having lung cancer if the levels of MK, TFPI, NSE and CA19-9 in the biological sample are greater than the reference levels of MK, TFPI, NSE and CA19-9 and the number of pack years of smoking by the subject is greater than the reference level of pack years.
A method for the diagnosis, prognosis and/or risk stratification of lung cancer in a subject having or suspected of lung cancer, the method comprising the step of detecting increased levels of midkine (MK), tissue factor pathway inhibitor (TFPI), neuron-specific enolase (NSE) and carbohydrate antigen 19-9 (CA19-9) and an increased amount of pack years of smoking by the subject relative to a control subject not having lung cancer.
A method of determining whether a subject is suffering from early lung cancer or benign lung disease, the method comprising the steps of:
- a. obtaining a biological sample from a subject;
- b. determining the levels of midkine (MK), tissue factor pathway inhibitor (TFPI), neuron-specific enolase (NSE) and carbohydrate antigen 19-9 (CA19-9) in the biological sample from the subject;
- c. determining the number of pack years of smoking of the subject;
- d. comparing the levels of MK, TFPI, NSE and CA19-9 in the biological sample to reference levels of MK, TFPI, NSE and CA19-9;
- e. comparing the number of pack years of smoking by the subject to a reference level of pack years;
- and
- f. providing a diagnosis of a subject having early lung cancer if the levels of in the MK, TFPI, NSE and CA19-9 in the biological sample are greater than the reference levels of MK, TFPI, NSE and CA19-9 and the number of pack years of the subject are greater than the reference level of pack years or a diagnosis of a subject having benign disease if the levels of MK, TFPI, NSE and CA19-9 in the biological sample are equal or less than the reference levels of MK, TFPI, NSE and CA19-9 and the number of pack years of the subject are equal or less than the reference level of pack years.
Dependencies are inferred from the claim text.