WO2011063026A2 - Digital cancer screening method - Google Patents

Abstract

A method involving successive occult screening and/or automated thermal assay screening to categorize and re-categorize patients in a manner allowing the patients to be treated to prevent cancer or attack diagnosed cancer.

Description

DIGITAL CANCER SCREENING METHOD

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 61/261,841 filed November 17, 2009.

SUMMARY

[0002] Millions of people die in the United States every year from cancer. Colorectal cancer, for instance, affects more than 100,000 persons per year in the United States alone. When the number of colorectal cancers occurring each year is combined with the number of cancers occurring in other digestive organs, including the esophagus and stomach, such cancers of the digestive system account for more occurrences of cancer than any other single form of the disease.

[0003] Early diagnosis of cancers of the digestive tract may be critical to the treatment of these types of cancers. For example, if the cancer is detected early in its development, the cure rate ranges from approximately 80% to about 90%. If, however, the disease is not detected until the later stages, the cure rate drops to about 25% or less.

[0004] Cancers of the digestive tract may be diagnosed in one instance after blood is detected in a patient's fecal matter because cancers of the digestive tract may bleed to a certain extent. The blood deposited in fecal matter may be excreted from the digestive system. In the early stages of the cancer, however, the presence of blood in the fecal matter may be difficult to detect. This is because the blood tends to be hidden (e.g., occult). As such, blood may not be detected until advanced stages of cancer when gross bleeding occurs and blood can be seen by the naked eye. Test equipment and test procedures have been developed for use by physicians in testing for the presence of occult blood in fecal matter. In one embodiment, occult equipment and test methods similar to those disclosed in U.S. Patent No. 5,316,732, granted on May 31, 1994, which is incorporated herein by reference, is utilized to facilitate the embodiments of the present invention. In another embodiment, occult equipment and test methods similar to those disclosed in U.S. Patent No. 3,996,006, granted December 7, 1976, which is incorporated herein by reference, is utilized to facilitate the embodiments of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] Fig 1. illustrates an occult screening image and automatic thermal assay screening images;

[0006] Fig. 2 illustrates a chart detailing the procedure for diagnosing cancer based on occult testing method;

[0007] Fig. 3 illustrates a chart detailing six possible outcomes associated with the occult testing method shown in Fig. 2; and

[0008] Fig. 4 illustrates a flow chart illustrating method/process steps associated with cancer screening according to one embodiment of the present invention.

DETAILED DESCRIPTION

[0009] For the purpose of promoting an understanding of the principles in accordance with the embodiments of the present invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications of the inventive features illustrated herein, and any additional applications of the principles of the invention as illustrated herein, which would normally occur to one skilled in the relevant art and having possession of this disclosure, are to be considered within the scope of the invention claimed.

[0010] As shown in Fig. 1, occult testing 100 may be used for detecting the presence of blood in the mouth 101, esophagus 103, small intestine 105, large intestine 107, stomach 109, rectum 111, anus 113 and ileum 115, among other parts of the human body. Occult testing may be specific to a particular organ, meaning that generally positive outcome is an indication that cancer may be associated with the particular organ. For example, a positive outcome on a sample acquired from the mouth may be an indication of cancer and/or tumor associated with the mouth.

[0011] Generally, occult testing is a procedure that requires three samples to be collected over the course of three days, although the number of samples and days can vary. To begin the process, the patient collects a stool sample every day for three days. In some embodiments, other types of samples may be collected including bodily fluids, mucus, saliva, urine and blood, among others. This may be done at home or at other locations including but not limited to, a physician's office, hospital, another healthcare setting, or any other suitable location. The samples may be provided to a physician or test center for analyzing for the presence of blood.

[0012] In general, the results of occult testing may be cross-correlated with those from automatic thermal assay (ATA) testing 110 which may target areas or regions including the mouth 101, esophagus 103, small intestine 105, large intestine 107, stomach 109, rectum 111, anus 113 and ileum 115. This will become more apparent in subsequent discussions.

[0013] As shown in Fig. 2, flow chart 200 illustrates the procedure for diagnosing cancer based on occult testing method. Sample 202 is first analyzed for blood. After sample 202 is analyzed, the patient is immediately categorized into one of two possible groups, with one group having a higher risk than the other. For instance, if sample 202 has a positive outcome for the presence of blood, the patient is categorized into group 204 which has a higher risk than group 206. If, on the other hand, the sample 202 has a negative outcome for the presence of blood, the patient is immediately categorized into group 206 which has a lower risk than 204.

[0014] After analysis of sample 202 is complete, the same procedure is repeated for sample 208. If sample 202 had a positive outcome and if sample 208 has a positive outcome for the presence of blood, the patient is categorized into group 210 which has a higher risk than group 212. If, on the other hand, sample 208 has a negative outcome for the presence of blood, the patient is immediately categorized into group 212 which has a lower risk than 210. If sample 202 had a negative outcome and if sample 208 has a positive outcome for the presence of blood, the patient is categorized into group 214 which has a higher risk than group 216. If, on the other hand, sample 208 has a negative outcome for the presence of blood, the patient is immediately categorized into group 216 which has a lower risk than 214.

[0015] After analysis of sample 208 is complete, the same procedure is repeated for sample 218. If both sample 202 and sample 208 had a positive outcome and if sample 218 has a positive outcome for the presence of blood, the patient is categorized into group 220 which has a higher risk than group 222. If, on the other hand, sample 218 has a negative outcome for the presence of blood, the patient is immediately categorized into group 222 which has a lower risk than 220. If sample 202 had a positive outcome and sample 208 had a negative outcome and, if sample 218 has a positive outcome for the presence of blood, the patient is categorized into group 224 which has a higher risk than group 226. If, on the other hand, sample 218 has a negative outcome for the presence of blood, the patient is immediately categorized into group 226 which has a lower risk than 224. If sample 202 had a negative outcome and sample 208 had a positive outcome and, if sample 218 has a positive outcome for the presence of blood, the patient is categorized into group 230 which has a higher risk than group 228. If, on the other hand, sample 218 has a negative outcome for the presence of blood, the patient is immediately categorized into group 228 which has a lower risk than 230. If both sample 202 and sample 208 had a negative outcome and, if sample 218 has a positive outcome for the presence of blood, the patient is categorized into group 232 which has a higher risk than group 234. If, on the other hand, sample 218 has a negative outcome for the presence of blood, the patient is immediately categorized into group 234 which has a lower risk than 232. As a result, six possible outcomes are possible. The six possible outcomes are summarized in chart 150 of Fig. 3.

[0016] Referring again to Fig. 2, based on the six outcomes of the occult testing, the patient can be placed into a risk category. The following risk categories can be used. The first category 236 is "High Risk." Patients in category 236 had a positive test outcome on each of the three samples and therefore are at high risk of having cancer. For such patients, further immediate testing is recommended to confirm or rule out cancer for patients. Exemplary tests include endoscopy, ultrasound, CT, MRI and other biochemical and clinical examinations that can confirm the presence of cancer. The second category 238, 242 is "Monthly Recheck." Patients in the Monthly Recheck category 238, 242 had a positive test outcome on two of the three samples and therefore are at moderate risk of having cancer. For such patients, a check up is recommended in one month to determine whether the risk has increased, remained constant or decreased. The third category 240, 243 is "Six Month Recheck." Patients in the Six Month Recheck category 240, 243 had a positive test outcome on one of the three samples and therefore have a moderate/low risk of having cancer. For such patients, a check up is recommended in six months to determine whether the risk has increased, remained constant or decreased. Finally, the fourth category 244 is "Yearly Recheck." Patients in the Yearly Recheck category 244 had a negative test outcome on each of the three samples and therefore have a low risk of having cancer. For such patients, a check up is recommended in one year to determine whether the risk has increased, remained constant or decreased. Of course, other risk categories can be included as well and the time before the check up can vary.

[0017] In one embodiment, the occult screening methods described above may be coupled with an automated thermal assay (ATA) system to facilitate health evaluation and cancer screening diagnosis of a human subject. In one instance, the combination allows correlation to be carried out between the two systems. In one embodiment, correlation of the two systems may increase sensitivity and/or specificity. For example, the sensitivity may range from at least about 90% to about 100%. In other instances, the specificity may range from at least about 90% to about 100%). In some embodiments, the specificity may be dependent on which body organ is being screened.

[0018] In one embodiment, the ATA system includes a computer system having a first module adaptable to define one or more bone structures of a human subject from one or more images of the human subject, a second module capable of identifying one or more parts of a human subject based on the one or more bone structures of the human subject, and a third module configured to establish one or more viscera and bowels, meridians and vessels, and acupoints of the human subject based on geometric ratios between the bone structures and parts of the human subject. In one embodiment, the system includes a fourth module adaptable to analyze one or more temperature features from the one or more images for identifying the one or more parts of the human subject. In one embodiment, the system includes a fifth module capable of dissecting the one or more images of the human subject into one or more regions to facilitate defining the one or more bone structures of the human subject. In one embodiment, the modules may be integrated in an application. In one embodiment, the system includes an electronic storage medium for storing the one or more viscera and bowels, meridians and vessels, and acupoints. Depending on the embodiment, the system may be automated and/or manual.

[0019] In one embodiment, a method of carrying out thermal assay testing includes acquiring one or more images of a human subject, defining one or more bones structures of the human subject using the one or more images, identifying one or more parts of the human subject based on the one or more bone structures and the one or more images, and establishing one or more meridians and vessels of the human subject based on geometric ratios between the bone structures and parts of the human subject. In one embodiment, the method includes analyzing one or more temperature features from the one or more images for identifying the one or more parts of the human subject. In one embodiment, the method includes dissecting the one or more images of the human subject into one or more regions to facilitate defining the one or more bone structures of the human subject. Depending on the embodiment, the steps may be automatically or manually executed. [0020] The automated thermal assay (ATA) system and method to facilitate health evaluation and medical diagnosis of a human subject similar to that described in U.S. Patent Application No. 12/163,748 filed June 27, 2008, are herein incorporated by reference.

[0021] Fig. 4 is a flow chart 400 illustrating the method/process steps associated with cancer screening according to one embodiment of the present invention. In step 402, a population may be subjected to cancer and/or tumor screening. The population may be as many as a few million subjects or as few as a couple hundred. In one embodiment, the population includes 100,000 subjects. In other examples, the population includes greater than 10,000 cases over a 10 year period. In some examples, the screening time may be seconds, minutes, hours, days, months, years or other suitable time periods. In one embodiment, the types of cancer and/or tumors associated thereof being screened include bladder cancer, breast cancer, colon and rectal cancer, endometrial cancer, kidney (renal cell) cancer, leukemia, lung cancer, melanoma, non-Hodgkin lymphoma, pancreatic cancer, prostate cancer, skin cancer (non-melanoma) and thyroid cancer, among others.

[0022] In step 404, each subject may be subjected to occult screening and/or ATA screening similar to that described above. In one embodiment, the results from the occult screening may be cross-correlated with the results from the ATA screening for further grouping of the subject. For cross-correlation, reference may be made to Fig. 1 whereby occult screening and ATA screening may be directed to various regions and organs of the body. In one example, positive outcome at the mouth via occult screening may be correlated with ATA screening of the mouth region. In some examples, positive outcome at the mouth via occult screening may be correlated with ATA screening of the mouth, and/or esophagus, and/or stomach, and/or other related regions and organs. In some embodiments, positive outcome in the colon via occult testing may be correlated with positive outcomes in the small and/or large intestines via ATA screening. In accordance with Chinese medicine principles, all the organs of the human body are related in one way or another. As such, positive outcomes via occult testing for a particular area may be mapped to at least one positive outcomes via ATA screening.

[0023] Returning now to Fig. 4, in step 406, the subject may be classified into at least one of three categories. The first category is the negative or low-risk group, where the subjects have generally negative outcomes from both occult screening and ATA screening for a particular type of cancer (e.g., colon, breast). In other instances, this category may include those with low risks for the type of cancer being screened for. In some embodiments, the various types of cancers may be screened in series or in parallel. The second category is the positive outcome group where the subjects have generally positive test results from both occult screening and ATA screening. A third category is an undetermined group where the subjects have generally mixed outcomes from the screenings (e.g., positive outcome from occult but negative from ATA, and vice versa). In other instances, this category may include those with high risks for the type of cancer being screened. In some embodiments, subjects may be classified into two categories (e.g., both positive outcome and undetermined). In one embodiment, approximately 80% of the subjects from the initial population may be grouped into the negative or low-risk group with the remaining approximately 20% in the positive or undetermined/high-risk groups.

[0024] In step 408, the positive outcome and undetermined subjects may be subjected to further recheck. In other instances, those classified in the negative or low-risk group may also choose to recheck although they may choose not to do so.

[0025] In step 410, the subject being rechecked may be subjected to either occult screening or ATA screening. In some instances, the subject being rechecked may be subjected to both screening techniques.

[0026] In step 412, the subjects may be once again re-classified to categories similar to those previously described. In one instance, those with negative outcomes for both occult screening and ATA screening are classified in the negative or low-risk group. In one instance, the subjects in this group may choose to not be screened or tested any further. Alternatively, the subjects may choose to be tested again in six months, or in one year, or in any other suitable time period. Those with positive outcomes for both occult screening and ATA screening are classified in the positive outcome group. In one instance, the subjects in this group may choose to undergo additional testing. Those with mixed test results as classified in the undetermined or high-risk group may also choose additional screenings and other types of treatments.

[0027] In step 414, those testing positive may be subjected to diagnostic testing including without limitation endoscopy, ultrasound, CT, MRI, and combinations thereof. In some embodiments, the subjects may also be subjected to other biochemical and/or clinical examinations.

[0028] In step 416, those with specific types of cancer and/or tumor may be diagnosed based on diagnostic testing and/or biochemical and clinical examinations. In some instances, the diagnosis may be based on Western medicine principles. Those with positive diagnosis of the specific types of cancer and/or tumor may be subjected to the corresponding cancer and/or tumor therapy at step 418. For example, the cancer and/or tumor therapy may include, among others, drugs, chemotherapy, radiation therapy and combinations thereof. In the alternative, those subjected to diagnostic testing and/or biochemical and clinical examinations may be classified as undetermined or high-risk if the findings are inconclusive. These subjects may be subjected to additional screening as described below.

[0029] In step 420, those classified as undetermined or high risk may again be subjected to occult screening and/or ATA screening. In one embodiment, prevention interventions may be incorporated. For example, a subject suspected of cancer in the mouth may be provided with the appropriate Chinese medication and/or Western medication directed to treating such an indication. Alternatively, Chinese medicine directed to treating other parts of the human body (e.g., esophagus, stomach) that may be effective against cancer in the mouth may also be utilized because of the relationships among the organs of the human body in accordance with principles of Chinese medicine. In some embodiments, subjects suspected of cancer in the stomach and/or colon may also be provided with appropriate Chinese and/or Western medications directed to treating such organs. Alternatively, subjects may also be provided with Chinese medications for treating other organs of the body in accordance with Chinese medicine principles. After taking the proper medications, the subject may again be subjected to occult screening and/or ATA screening for determining positive and/or negative outcomes. Depending on the effectiveness of the medication, changes and/or improvements may be detected by occult screening and/or ATA screening. These changes may again be cross-correlated with each other. For example, occult testing indicating positive outcome in the mouth may be confirmed with positive outcomes in the mouth and esophagus using ATA screening. In other instances, occult testing indicating positive outcome (e.g., blood in the sample) in the colon may be correlated with positive outcomes in the small and large intestines via ATA screening.

[0030] In step 422, those classified as positive outcome may choose to undergo the diagnostic and/or biological and clinical examinations similar to that outlined in step 414 and subsequent treatments as discussed above. Alternatively, those classified as undetermined and/or high risk may again be subjected to additional occult screening and/or ATA screening in step 424. Similarly, prevention interventions may be incorporated. The occult screening and/or ATA screening and the prevention interventions may be substantially similar to those in step 420.

[0031] In step 426, those classified as positive outcome may choose to undergo diagnostic testing and/or biochemical and clinical examinations similar to those described above. Alternatively, those classified as undetermined or high-risk may also choose to undergo similar treatments. In some embodiments, those classified as undetermined or high-risk may again choose to undergo additional occult screening and/or ATA screening and/or prevention interventions similar to those outlined in steps 420 or 424.

[0032] In some embodiments, certain steps may be eliminated and/or added as necessary. For example, steps 406 and 412 may be combined thereby eliminating steps 408 and 410. Alternatively, steps 424 and 426 may be combined with steps 420 and 422, respectively. In some embodiments, additional screening similar to those of steps 424 and 426 may be added for a subject with positive outcome before having the subject being subjected to diagnostic and/or biochemical and clinical examinations.

[0033] Because of the ease and speed of occult and ATA screenings, those with undetermined test results and/or high-risks for particular types of cancer may be tested more quickly and easily than using conventional diagnostic equipment (e.g., MRI, CT, endoscopy). Furthermore, the low cost of the screenings may allow a majority of the population to be readily screened and thereby allow preventative steps to be taken.

[0034] Although the invention has been described in detail with reference to several embodiments, additional variations and modifications exist within the scope and spirit of the invention.

Claims

WE CLAIM:

1. A method comprising:

initially screening a group of people for cancer and/or tumors utilizing occult screening and/or automated thermal assay screening;

based on results of the initial screening, categorizing people as negative/low risk, undetermined/high risk or positive;

performing first recheck screening of people categorized as undetermined/high risk utilizing occult screening and/or automated thermal assay screening;

based on results of the recheck screening categorizing people as negative/low risk, undetermined/high risk or positive;

then:

for people categorized as positive during the first recheck screening:

subjecting people to diagnostic testing and/or biochemical and clinical examinations; and

based on a diagnosis from said diagnostic testing and/or biochemical and clinical examinations, subjecting people to therapy for said diagnosis;

for people categorized as undetermined/high risk during the first recheck screening:

performing second recheck screening utilizing occult screening and/or automated thermal assay screening, and performing preventative interventions;

for people categorized as positive during the second recheck screening:

subjecting people to diagnostic testing and/or biochemical and clinical examinations; and

based on a diagnosis from said diagnostic testing and/or biochemical and clinical examinations, subjecting people to therapy for said diagnosis;

for people categorized as undetermined/high risk during the second recheck screening:

performing third recheck screening utilizing occult screening and/or automated thermal assay screening, and performing preventative interventions;

for people categorized as positive during the third recheck screening: subjecting people to diagnostic testing and/or biochemical and clinical examinations; and

based on a diagnosis from said diagnostic testing and/or biochemical and clinical examinations, subjecting people to therapy for said diagnosis.