Liquid biopsy yield enhancement
OwnerSeema Singhal, Jayesh Mehta +2inventors
InventorsSeema Singhal, Jayesh Mehta, Neil Mehta, Aran Mehta
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Abstract
Provided herein are methods, kits, systems, and compositions or liquid biopsy yield enhancement.
Claims57
A method of analyzing a fluid sample obtained from a subject, comprising determining presence or absence of one or more tumor cells or tumor DNA in the fluid sample, wherein the subject was previously administered a cytokine or growth factor in an amount effective to mobilize release of the one or more tumor cells or tumor DNA into circulation.
A method of detecting one or more tumor cells or tumor DNA in a fluid sample obtained from a subject, comprising:
- a. administering to the subject a cytokine or growth factor in an amount effective to stimulate release of the one or more tumor cells or tumor DNA into circulation;
- b. obtaining the fluid sample from the subject after administering the cytokine or growth factor to the subject;
- and
- c. determining presence or absence of the released one or more tumor cells or tumor DNA in the fluid sample.
A method of treating cancer in a subject in need thereof, comprising
- a. administering to the subject a cytokine or growth factor in an amount effective to stimulate release of one or more tumor cells or tumor DNA into circulation;
- b. obtaining a fluid sample from the subject after administering the cytokine or growth factor to the subject;
- c. determining presence or absence of the released one or more tumor cells or tumor DNA in the fluid sample;
- and
- d. administering at least one cancer therapeutic to the subject if presence of the released one or more tumor cells or tumor DNA in the fluid sample is detected.
A method of treating cancer in a subject in need thereof, comprising administering at least one cancer therapeutic to the subject if one or more tumor cells or tumor DNA has been detected in a fluid sample obtained from the subject following administration of a cytokine or growth factor in an amount effective to stimulate release of the one or more tumor cells or tumor DNA into circulation of the subject.
A method of prognosing a subject having cancer, comprising genetically profiling one or more tumor cells or tumor DNA analytes, wherein the one or more tumor cells or tumor DNA analytes were obtained from a fluid sample obtained from the subject, wherein the subject was previously administered a cytokine or growth factor in an amount effective to stimulate release of the one or more tumor cells or tumor DNA into circulation, wherein the genetic profile of the one or more tumor cells or tumor DNA analytes is indicative of the subject's prognosis.
A method of prognosing a subject having cancer, comprising:
- a. administering to the subject a cytokine or growth factor in an amount effective to stimulate release of one or more tumor cells or tumor DNA analytes into circulation;
- b. obtaining a fluid sample from the subject after administering the cytokine or growth factor to the subject;
- and
- c. genetically profiling the released one or more tumor cells or tumor DNA analytes in the fluid sample,
- wherein the genetic profile of the one or more tumor cells or tumor DNA analytes is indicative of the subject's prognosis.
A method of detecting cancer in a subject, comprising detecting one or more tumor cells or tumor DNA analytes, wherein the one or more tumor cells or tumor DNA analytes were obtained from a fluid sample obtained from the subject, wherein the subject was previously administered a cytokine or growth factor in an amount effective to stimulate release of the one or more tumor cells or tumor DNA into circulation, wherein the detection of the one or more tumor cells or tumor DNA analytes is indicative of cancer in the subject.
A method of detecting cancer in a subject, comprising:
- a. administering to the subject a cytokine or growth factor in an amount effective to stimulate release of one or more tumor cells or tumor DNA analytes into circulation;
- b. obtaining a fluid sample from the subject after administering the cytokine or growth factor to the subject;
- and
- c. detecting the released one or more tumor cells or tumor DNA analytes in the fluid sample,
- wherein the detection of the one or more tumor cells or tumor DNA analytes is indicative of cancer in the subject.
The method of any one of the preceding claims, wherein the cytokine or growth factor is selected from erythropoietin, G-CSF, GM-CSF, SCF, IL-3, KGF, and plerixafor.
The method of any one of the preceding claims, wherein the administering step further comprises administering to the subject one or more anticancer therapeutics.
The method of any one of the preceding claims, wherein the fluid sample is a blood sample.
The method of any one of the preceding claims, wherein the fluid sample is an ascites, cerebrospinal fluid, lymph, sweat, urine, tears, saliva, pleural fluid, pericardial fluid, cavity rinse, or organ rinse sample.
The method of any one of the preceding claims, wherein the cytokine or growth factor is administered after completing a round of treatment for cancer, optionally after completing sufficient number of rounds of chemotherapy to render the cancer undetectable by conventional means (i.e. achieve complete remission by conventional criteria excluding MRD detection).
The method of any one of the preceding claims, wherein the cytokine or growth factor is administered when the subject is determined to be in remission or suspected by a clinician to be in complete remission from cancer.
The method of any one of the preceding claims, wherein the administration of the cytokine or growth factor, the obtaining of the fluid sample from the subject, and the determining presence or absence of the released one or more tumor cells or tumor DNA is performed once.
The method of any one of the preceding claims, wherein the administration of the cytokine or growth factor, the obtaining of the fluid sample from the subject, and the determining presence or absence of the released one or more tumor cells or tumor DNA is performed at least two times.
The method of any one of the preceding claims, wherein the administration of the cytokine or growth factor, the obtaining of the fluid sample from the subject, and the determining presence or absence of the released one or more tumor cells or tumor DNA is performed after the subject has tested negative for minimal residual disease.
The method of any one of the preceding claims, wherein the cancer is known to express CXCR4.
The method of any one of the preceding claims, wherein the cancer is selected from adrenal cancer, anal cancer, bile duct cancer, bladder cancer, bone cancer, cancer of the brain or central nervous system, basal cell skin cancer, breast cancer, cervical cancer, colorectal cancer, endometrial cancer, esophageal cancer, eye cancer, gallbladder cancer, gastrointestinal carcinoid tumors, gastrointestinal stromal tumor (GIST), gastric cancer, glioma, glioblastoma, head and neck cancer (including head and neck squamous cell carcinoma), Hodgkin disease, Classical Hodgkin Lymphoma, diffuse large B cell lymphoma, follicular lymphoma, Kaposi sarcoma, kidney cancer, laryngeal and hypopharyngeal cancer, leukemia (including acute myeloid leukemia), liver cancer (including hepatocellular carcinoma), lymphoma, melanoma (including unresectable or metastatic melanoma), prostate cancer, lung cancer (including non-small cell lung cancer and metastatic non-small cell lung cancer) malignant mesothelioma, merkel cell carcinoma, metastatic urothelial carcinoma, multiple myeloma, myeloma, myelodysplastic syndrome, nasal cavity and paranasal sinus cancer, nasopharyngeal cancer, neuroendocrine cancer, neuroblastoma, non-Hodgkin lymphoma, oral cavity and oropharyngeal cancer, osteosarcoma, ovarian cancer, pancreatic cancer, penile cancer, pituitary tumors, renal cancer (including renal cell carcinoma), retinoblastoma, hematological malignancy, rhabdomyosarcoma, salivary gland cancer, sarcoma, squamous cell skin cancer, small intestine cancer, stomach cancer, testicular cancer, thymus cancer, thyroid cancer, uterine cancer, and vaginal cancer.
The method of any one of the preceding claims, wherein the one or more tumor cells or tumor DNA is released into circulation from a non-blood compartment.
The method of any one of the preceding claims, wherein the presence or absence of the released one or more tumor cells or tumor DNA in the fluid sample is determined by flow cytometry.
The method of any one of the preceding claims, wherein the presence or absence of the released one or more tumor cells or tumor DNA in the fluid sample is determined by an assay with a sensitivity of at least 1 in 100,000 cells.
A kit, comprising a pharmaceutically acceptable dosage form of a growth factor or cytokine and instructions for use according to any one of the preceding claims.
A system for liquid biopsy yield enhancement, comprising
- a. one or more pharmaceutically acceptable dosage forms of a cytokine or growth factor;
- b. one or more reagents, devices, or kits for obtaining a fluid sample from a subject in need thereof;
- and
- c. one or more reagents, devices, and/or apparatuses for analyzing tumor cells and/or tumor DNA in the fluid sample.
Dependencies are inferred from the claim text.