Method for the diagnosis and prognosis of cancer
Inventors
HAZNADAR, Majda • MATHE, Ewy • Patterson, Andrew D. • HARRIS, Curtis Craig • Gonzalez, Frank • KRAUSZ, Kristopher • Manna, Soumen
Assignees
National Institutes of Health NIH • US Department of Health and Human Services
Publication Number
US-11555818-B2
Publication Date
2023-01-17
Expiration Date
2034-07-11
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Abstract
The present invention provides methods and materials for diagnosing cancer in an individual using a tissue, blood or urine sample from the patient. Specifically, the disclosed method comprises determining the level of one or more metabolite selected from the group consisting of creatine riboside, metabolite 561+, cortisol sulfate and N-acetylneuraminic acid. The present invention also provides a method for determining the prognosis of a cancer patient by determining the level of one or more metabolite selected from the group consisting of creatine riboside, metabolite 561+, cortisol sulfate and N-acetylneuraminic acid. Also provided are kits for detecting cancer or determining the prognosis of a cancer patient.
Core Innovation
The invention provides methods and materials for diagnosing cancer in an individual using tissue, blood, or urine samples by determining the levels of one or more metabolites selected from creatine riboside, metabolite 561+, cortisol sulfate, and N-acetylneuraminic acid. Elevated levels of these metabolites relative to individuals free of cancer indicate the presence of cancer. The methods also extend to prognosing cancer patients by measuring these metabolites' levels, with elevated levels indicating a prognosis potentially related to reduced survival time.
The problem being solved addresses the limitations of current clinical methods for early detection and prognosis of lung cancer, such as spiral CT scanning, which exhibits high false positive rates, radiation exposure risks, expense, and limited applicability. There is a need for safer, less expensive, and more accurate diagnostic and prognostic tools. The invention provides such methods by using specific biomarkers detectable in body fluids or tissues that can indicate cancer presence and prognosis noninvasively and effectively.
Claims Coverage
The patent contains a set of independent claims focused on a method for treating cancer by determining a metabolite profile signature comprising specific metabolites and administering therapy based on the detection of elevated levels indicative of cancer.
Method for determining cancer presence by metabolite profile signature
A method comprising measuring levels of at least two metabolites selected from creatine riboside, metabolite 561+, cortisol sulfate, and N-acetylneuraminic acid in a sample from an individual, or measuring levels of one or more metabolites selected from creatine riboside and metabolite 561+. Determining presence of cancer when these metabolite levels are elevated compared to a control sample.
Comprehensive metabolite analysis for cancer detection
Determining levels of at least three or all four compounds (creatine riboside, metabolite 561+, cortisol sulfate, and N-acetylneuraminic acid) in an individual’s sample, where elevated levels indicate the presence of cancer.
Sample source for metabolite measurement
Obtaining the metabolite profile from body tissue or body fluids, including blood, plasma, serum, or urine.
Cancer types targeted
The method specifically applies to lung cancer, including adenocarcinoma and squamous cell carcinoma subtypes.
The claims broadly cover a method of diagnosing cancer and treating based on elevated metabolite levels selected from specified biomarkers in body tissues or fluids, with specificity to lung cancer types. The inventive features focus on metabolite profiling, sample sources, and cancer subtypes.
Stated Advantages
The invention provides a diagnostic method that is inexpensive, requires only a small patient sample, and can be performed quickly and safely.
The diagnostic approach reduces false positives associated with imaging techniques and is less invasive compared to tumor-based assays.
The method permits early detection of cancer, which is critical for improving survival rates.
The use of urine and other body fluids enables noninvasive sampling.
Documented Applications
Diagnosing cancer in individuals by detecting elevated levels of specific metabolites in tissue or body fluids such as urine, blood, serum, and plasma.
Determining prognosis for cancer patients by measuring elevated levels of creatine riboside, metabolite 561+, cortisol sulfate, and N-acetylneuraminic acid, which correlate with survival outcomes.
Monitoring efficacy of cancer treatment by comparing pre-treatment and post-treatment levels of these metabolites.
Identifying individuals at risk or suspected of having lung cancer, including adenocarcinoma and squamous cell carcinoma.
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