Early detection of colorectal cancer
Inventors
OSKERITZIAN, CAROLE A. • Berger, Franklin • CHUMANEVICH, ALENA P. • Fuseler, John W. • Kumte, Nabihah I. • Aladhami, Ahmed
Assignees
Publication Number
US-12253521-B2
Publication Date
2025-03-18
Expiration Date
2039-12-19
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Abstract
Methods and systems for detection of precancerous colorectal cancerous lesions and early stage colorectal cancer are described. The methods and systems include examination of a rectal cell sample for the presence of mast cells in a field effect detection regime. The methods can incorporate swab-based cell collection, optionally storage and transportation of a cell sample, and/or computer-aided diagnosis.
Core Innovation
The invention provides methods and systems for early detection of colorectal cancer (CRC) and precancerous colon polyps by examining rectal cell samples for the presence of mast cells within a field effect detection regime. The approach relies on the premise that the cellular composition of cells sloughed from premalignant colons differs from those of healthy colons, specifically by the presence of mast cells which correlates with precancerous polyps or CRC elsewhere in the colon.
The method involves collecting a rectal cell sample via swabbing, staining the collected sample with a mast cell-identifying stain such as chloroacetate esterase or methylene blue, and examining the stained sample to determine if mast cells are present. Detection of mast cells in the rectal cell sample indicates the likely presence of precancerous or cancerous lesions in the colon. The system can utilize swab-based collection, storage and transport of samples in buffer-filled containers, and may incorporate computer-aided diagnosis to identify and quantify mast cells using digital imaging and morphometric analysis.
This invention addresses the problem of current CRC screening methods, which suffer from low adherence rates, low sensitivity (for FIT), invasiveness (for colonoscopy), high cost, burdensome sample collection, or reliance on expensive equipment and highly trained personnel. By providing a simple, minimally invasive, and potentially low-cost screening method using swab collection and accessible imaging analysis, the disclosed methods and systems seek to improve early detection of CRC and precancerous lesions.
Claims Coverage
The patent contains three independent claims, each outlining a method for detecting colorectal cancer or precancerous colon polyps using rectal cell sampling analyzed via computerized imaging to detect mast cells.
Computerized imaging-based detection of mast cells in rectal cell samples
A method comprising: - Swabbing a rectal area of a subject to collect a cell sample on a swab; - Sealing the cell sample in a container carrying a buffer solution; - Detecting the presence or quantity of sloughed colonic mast cells according to a computerized imaging approach, which includes identifying stained-positive cells and isolating individual regions of interest based on a Hue, Saturation, Intensity (HSI) color model; - Using the presence of mast cells as an indicator of colorectal cancer or precancerous polyps in the colon.
HSI-based morphometric boundary conditions for mast cell identification
A method as above, further specifying that in the computerized imaging approach, isolated regions of interest comprise: - Hue values between 214 and 255, - Saturation values between 15 and 208, and - Intensity values between 61 and 150; To distinguish mast cells from other cells in the stained sample.
Integration of morphometric descriptor boundary conditions in computerized detection
A method as above, wherein the computerized imaging approach further includes definition of boundary conditions for morphometric descriptors, and the regions of interest meet the specific HSI value ranges (Hue: 214–255; Saturation: 15–208; Intensity: 61–150). The detection of sloughed colonic mast cells is used to indicate the presence of colorectal cancer or precancerous polyps in the colon.
In summary, the independent claims cover a swab-based rectal sampling method in which mast cell detection serves as a biomarker for colorectal lesions, and distinctive computerized imaging techniques—relying on HSI color modeling and morphometric boundaries—enable accurate identification of mast cells in collected samples.
Stated Advantages
The method provides a low cost, accessible, and less invasive screening approach for colorectal cancer compared to conventional methods.
Sample collection using a swab is minimally invasive, does not require anesthesia, can be performed quickly, and is suitable for self-collection or by healthcare providers.
The method enables rapid sample processing, potentially in less than one hour, and results can be available the same day as collection.
Computerized analysis does not require expensive equipment or highly trained personnel, and is accessible to both private practice and clinical settings.
Testing systems are portable and can be used in home settings or clinics, eliminating the need for hospital visits.
The approach allows for standardized and automated measurements, optimizing clinical workflow and enabling objective diagnosis.
The method holds promise for increasing uptake of colorectal cancer screening and early detection of disease.
Documented Applications
Detection of colorectal cancer and precancerous colon polyps in human subjects through noninvasive rectal cell sample analysis for mast cell presence.
Application in primary care settings, clinics, and home environments for early screening and diagnosis of colorectal neoplasia.
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