US2021285950A1PendingUtilityA1
Compositions, methods and kits for diagnosis of lung cancer
Est. expiryMay 5, 2036(~9.8 yrs left)· nominal 20-yr term from priority
G01N 33/5752G06N 7/01G01N 2560/00G16H 40/63G16B 20/00G16H 50/20G16H 30/20G16H 50/30G01N 33/6848G01N 2800/00G06N 7/005G01N 33/57423
66
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Claims
Abstract
Methods are provided for identifying biomarker proteins that exhibit differential expression in subjects with a first lung condition versus healthy subjects or subjects with a second lung condition. Also provided are compositions comprising these biomarker proteins and methods of using these biomarker proteins or panels thereof to diagnose, classify, and monitor various lung conditions. The methods and compositions provided herein may be used to diagnose or classify a subject as having lung cancer or a non-cancerous condition, and to distinguish between different types of cancer (e.g., malignant versus benign, SCLC versus NSCLC).
Claims
exact text as granted — not AI-modified1 . A method of treating a pulmonary nodule in a subject, comprising:
(a) performing an immunoassay to measure expression levels of a panel of proteins present in a blood sample obtained from the subject, wherein the panel of proteins comprises LG3BP and C163A; (b) calculating a probability of lung cancer score based on the measurements of step (a) and clinical risk factors comprising age, smoking status, nodule diameter, nodule spiculation status and nodule location; (c) ruling out lung cancer for the subject if the score in step (b) is lower than a pre-determined score, and ruling in lung cancer for the subject if the score in step (b) is equal to or higher than a pre-determined score; and (d) if the lung cancer is ruled out in step (c), then monitoring the subject periodically, and if the lung cancer is ruled in in step (c), then performing a treatment protocol on the subject.
2 .- 3 . (canceled)
4 . The method of claim 1 , wherein the subject has low to moderate cancer risk.
5 . The method of claim 1 , further comprising a physician's assessment of cancer risk.
6 . The method of claim 5 , wherein the subject is assigned a physician's assessment of cancer risk from between 0 to 1.
7 . The method of claim 6 , wherein the cancer risk is determined by a cancer risk predictor C i (k) determined as
Ci
(
k
)
=
{
0
,
if
pCA
(
k
)
≤
T
i
pCA
(
k
)
,
otherwise
where the decision threshold T i is the median value of {Si(k)} of patients with nodules no larger than 15 mm.
8 . The method of claim 1 , wherein the periodic monitoring is a pulmonary function test (PFT), pulmonary imaging, a biopsy or any combination thereof.
9 . The method of claim 8 , where said pulmonary imaging is an x-ray, a chest computed tomography (CT) scan, or a positron emission tomography (PET) scan.
10 . The method of claim 1 , wherein said pulmonary nodule has a diameter of less than or equal to 3 cm.
11 . The method of claim 1 , wherein said pulmonary nodule has a diameter of about 0.8 cm up to 3.0 cm.
12 . (canceled)
13 . The method of claim 1 , the panel comprises LG3BP and C163A and the reversal ratio is 0.07.
14 .- 30 . (canceled)
31 . The method of claim 1 , wherein the immunoassay is enzyme-linked immunosorbent assay (ELISA).
32 . The method of claim 1 , wherein the step (a) comprises contacting the blood sample with a LG3BP antibody and a C163A antibody.
33 . The method of claim 1 , wherein the score in step (b) is determined as XL_2(k), for a subject k, wherein
XL_
2
(
k
)
=
{
max
(
0
,
p
(
k
)
-
0
.5
)
,
log
2
(
L
G
3
B
P
C
1
6
3
A
)
≤
.38
p
(
k
)
,
log
2
(
L
G
3
B
P
C
1
6
3
A
)
>
.38
p
(
k
)
=
e
X
1
+
e
X
X
=
-
6.8272
+
0.0391
*
Age
+
0.7917
*
Smoker
+
0.1274
*
Diameter
+
1.0407
*
Spiculation
+
0.7838
*
Location
wherein Age is the age of the subject in years, Smoker is 1 if the subject is a former or current smoker otherwise 0, Diameter is the size of the lung nodule in mm, Spiculation is 1 if the lung nodule is spiculated otherwise 0 and Location is 1 if the lung nodule is located in an upper lung lobe otherwise 0.
34 . The method of claim 1 , wherein the treatment protocol is a pulmonary function test (PFT), pulmonary imaging, a biopsy, a surgery, a chemotherapy, a radiotherapy, or any combination thereof.
35 . The method of claim 34 , wherein the imaging is an x-ray, a chest computed tomography (CT) scan, or a positron emission tomography (PET) scan.
36 . The method of claim 1 , wherein when lung cancer is ruled out, the subject avoids an invasive procedure.
37 . The method of claim 36 , wherein the invasive procedure is a biopsy and/or a surgery.Cited by (0)
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