Early Pancreatic Cancer detection kit

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Early Pancreatic Cancer detection kit
Currently, there is no reliable diagnostic tool or established early detection method for
pancreatic cancer, precluding a cure for the patient. In the United States, pancreatic cancer is
the fourth most common cause of deaths due to cancer. The disease occurs most often in the
developed world, where about 70% of the new cases in 2012 originated. Pancreatic
adenocarcinoma, which accounts for 95% of pancreactic cancers have a very poor prognosis:
after diagnosis, 25% of people survive one year and 5% live for five years, because most are
diagnosed in the late stages. For cancers diagnosed early, the five-year survival rate rises to
about 20%. Neuroendocrine cancers have better outcomes; at five years from diagnosis, 65% of
those diagnosed are living, though survival varies considerably depending on the type of tumor.
The pancreas has multiple functions, served by endocrine cells in the islets of Langerhans and
the exocrine acinar cells. The exocrine group of cells are dominated by the most common
cancer - pancreatic adenocarcinoma (variations of this name may add "invasive" and "ductal"),
representing about 85% of all pancreatic cancers. The next most common type, acinar cell
carcinoma of the pancreas, arises in the clusters of cells that produce these enzymes, and
represents 5% of exocrine pancreas cancers. Cystadenocarcinomas account for 1% of
pancreatic cancers, and they have a better prognosis than the other exocrine cancers. There are
also a small minority of tumors that arise elsewhere in the pancreas that are mainly
pancreatic neuroendocrine tumors (PanNETs). Pancreatic Cancer has the lowest five-year
survival rate of any common cancer and, sadly one that has barely improved in 40 years. More
than 80% of people with the disease are diagnosed when it has already spread, so they are not
eligible for surgery to remove the tumor – which is currently the only potential cure. Those at
higher risk include people with a family history of the cancer, heavy smokers, obese people and
people over 50 who are newly diagnosed with diabetes.
Diagnosing and Treating Pancreatic Cancer
The pancreas is deep within the body, so early tumors cannot be seen or felt, and 4 of 5
patients are diagnosed only after it has spread. Patients usually have no symptoms until the
cancer has spread to other organs. While surgery to remove the tumor or the organ can cure up
to 50 percent of early-stage pancreatic cancer, doctors see few patients at this stage. When
diagnosed early, surgical resection offers the best chance for long term control of pancreatic
cancer, therefore, tests sensitive enough to detect pancreatic cancer in the earliest stages are
urgently needed. Until a reliable early detection test is developed, screening protocols for highrisk individuals are presently used. Doctors agree that having two or more close family
members with pancreatic cancer puts a person at high risk for the disease. Two types of
research programs for high-risk individuals are surveillance programs and family registries. The
goal of surveillance programs is to detect early pancreatic cancer and pre-cancerous lesions in
patients who are at high risk for developing pancreatic cancer. These programs involve regular
monitoring of high-risk persons using tests such as EUS, CT scan and/or ERCP. Participants may
also undergo novel imaging procedures, be tested for genes associated with hereditary
pancreatic cancer, and have biological fluids, such as blood and pancreatic juice, collected and
analyzed. Using Blood tests doctors can monitor certain substances, such as carcinoembryonic
antigen (CEA) and CA 19-9, which are sometimes elevated in people with pancreatic cancer.
However, blood tests don't allow for early detection of pancreatic cancer, because these levels
may not rise until pancreatic cancer is advanced, if at all.
Diagnosing pancreatic cancer usually happens when someone comes to the doctor after
experiencing weeks or months of symptoms. Pancreatic cancer symptoms frequently
include abdominal pain, weight loss, itching, or jaundice (yellow skin). A doctor then embarks
on a search for the cause, using the tools of the trade and patient history: Pancreatic cancer
often can be challenging to diagnose. Symptoms usually do not appear in the early stages, and
if they do they may be mistaken for signs of another condition. Also, the pancreas is deep inside
the body, behind several other organs. This makes it difficult to feel or see without proper
equipment.
Treating pancreatic cancer is challenging when it's discovered at an advanced stage. Accurate
diagnosis and staging are important because they help choose the best type of treatment.
Treatment includes highly invasive surgery for removal of cancer or pancreatic organ for which
hormones would need to be taken to replace those lost. The alternative is also invasive; long
treatments of chemotherapy which may extend life briefly as this is typically the only treatment
for patients who are too advanced for surgery. Several medical tests usually are required to find
and stage pancreatic cancer including the following:
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CBC count
Hepatobiliary tests: Patients with obstructive jaundice show significant elevations in
bilirubin (conjugated and total), ALP, GGT, and, to a lesser extent, AST and ALT.
Serum amylase and/or lipase levels: Elevated in less than 50% of patients with
resectable pancreatic cancers and in only 25% of patients with unresectable tumors
Tumor markers such as CA 19-9 antigen and CEA: 75-85% have elevated CA 19-9 levels;
40-45% have elevated CEA levels
Imaging studies that aid in the diagnosis of pancreatic cancer include the following:
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Computed Tomography (CT) scanning
Transcutaneous ultrasonography
Endoscopic ultrasonography (EUS)
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Magnetic resonance imaging
Endoscopic retrograde cholangiopancreatography (MRCP)
Positron emission tomography scanning
Ultrasound
MR angiography (MRA)
Percutaneous transhepatic cholangiography (PC)
Neuroendocrine tumors tests:
 Somatostatin receptor scintigraphy (SRS) or OctreoScan
Blood tests for exocrine pancreatic cancers are often not helpful for diagnosis
Liver function tests: Jaundice (yellowing of the skin and eyes) is often one of the first signs of
pancreatic cancer, but it can have many causes other than cancer. Doctors often get blood tests
to assess liver function in people with jaundice to help determine its cause.
Tumor markers: Tumor markers are substances that can sometimes be found in the blood
when cancer is present. Two tumor markers may be helpful in pancreatic cancer:
CA 19-9: is a substance often released into the blood by exocrine pancreatic cancer cells,
although it often can’t be detected until the cancer is already advanced.
Carcinoembryonic antigen (CEA): is another tumor marker that might help find advanced
pancreatic cancer in some people, but it is not used as often as CA 19-9.
Molecular testing of the tumor (other markers). Laboratory tests on a tumor sample to
identify specific genes, proteins, and other factors unique to the tumor. Biomarkers for
pancreatic cancer include RAS, SPARC, hENT1, and DPC4.
Blood tests for pancreatic neuroendocrine tumors are more helpful for diagnosis
Blood tests looking at the levels of certain pancreatic hormones can often help diagnose
pancreatic neuroendocrine tumors (NETs).
For insulinomas, insulin, glucose, and C-peptide levels are measured. The diagnosis of an
insulinoma is made when there is low blood glucose with high levels of insulin and C-peptide.
Other pancreatic hormones, such as gastrin, glucagon, somatostatin, pancreatic polypeptide,
and VIP (vasoactive intestinal peptide) can be measured in blood to help diagnose pancreatic
NETs. Measuring the level of a substance called chromogranin A (CgA) can be very helpful. This
level goes up in most cases of pancreatic NETs — even tumors that don’t make excess
hormones (non-functioning tumors).
Carcinoid tumors: For carcinoids, a blood test may be done to look for serotonin, which is made
by many of these tumors. This test can help diagnose many (but not all) carcinoid tumors. Other
common tests to look for carcinoids include blood tests for chromogranin A (CgA), neuronspecific enolase (NSE), substance P, and gastrin.
Biopsy
A person’s medical history, physical exam, and imaging test results may strongly suggest
pancreatic cancer, but usually the only way to be sure is to remove a small sample of tumor and
look at it under the microscope.
Percutaneous (through the skin) biopsy: Endoscopic biopsy is used to attain the tissue
Stages of Pancreatic Cancer
The stage of the cancer is a measure of the extent to which the tumor has grown in the
pancreas and has spread to other sites in the body. Pancreatic cancer can be assigned one of
the following four stages:
Stage I – The tumor is less than 2 cm in diameter and is completely contained within the
pancreas.
Stage II– The tumor has begun to grow outside of the pancreas, but has not invaded a major
blood vessel. Stage II pancreatic cancer may have spread to nearby lymph nodes, but not to
distant sites.
Stage III – The tumor is growing outside of the pancreas, and has moved into nearby large
blood vessels or major nerves.
Stage IV – The cancer has spread to other parts of the body, such as the liver or the peritoneum
(inner lining of the abdomen).
Current Research and the future
The American Cancer Society says that up to 10% of pancreatic cancers may be caused by
inherited DNA changes. Studies are ongoing to see if aggressive screening with endoscopic
ultrasound works for early detection of pancreatic cancer in healthy family members. Early
results are promising. However, endoscopy is an invasive procedure, so its use is only justified
in people already at high risk for pancreatic cancer.
Using genetic analysis, scientists are also looking for specific genes and changes within genes
that are associated with pancreatic cancer. Preliminary studies have revealed that a significant
number of genes are abnormally active in pancreatic cancer cells. Scientists are also analyzing
biological fluids, such as saliva and blood, for biomarkers that are present in patients with
pancreatic cancer that may be used in diagnosing early stages. There are also new imaging
techniques that are showing promise in detecting pancreatic cancer in its early stages.
However, a diagnostic test involving any biomarker must be able to distinguish between a
person with pancreatic cancer and an unaffected individual with near 100% accuracy and
possibly detect low levels. Several markers, including the ones mentioned previously (CA-19-9
and CEA), have been tested as diagnostic tools with promising results but not at 100% accuracy.
It is doubtful that one marker alone will be specific enough to reliably diagnose all types of
pancreatic cancer. It is more likely that a group, or panel, of many markers will need to be
combined to create an accurate test. As far as other tests, imaging tests can be expensive and
uncomfortable as well as not effective in viewing small changes such as those that may occur in
early stages. What is needed is a robust and accurate diagnostic test using either blood, urine,
saliva or other fluid that can be attained noninvasively.
The Challenge
The seeker specifically wishes to identify a robust method that:
1. Uses blood, saliva or urine samples preferably, but other fluids will be considered if it is
minimally invasive.
2. Minimizes the time for diagnosis to hours.
3. Easy to use and cost effective and can be done at point of care or reference lab.
4. Freedom to practice: no IP, however licensing opportunities will be considered.
In Scope
1. Protocols that describe assays that include procedural steps with reagents and instruments.
2. Scientific explanations and reasons for the recommended techniques.
3. Reference to papers or clinical trials supporting the techniques.
Out of Scope
The Seeker is not interested in a solution that:
• Consists of a literature survey
• Requires excessively expensive reagents or supplies
• Has many or time-consuming steps
• Is primarily theoretical and would be difficult to assess efficacy in a practical manner
• Has negative health and safety issues or environmental impact
Criteria that must be met:
1. Level of detail provided for the proposed protocol such as reagents, solution formulations,
consumables, equipment
2. Accessibility and cost of the technological solution, i.e., does not require development of an
entirely new technology.
3. Ease of method for use at the point of care
Project Deliverables
Challenge solutions should provide:
1. A detailed description and explanation of the proposed solution or solutions;
2. Persuasive scientific rationale and, ideally, experimental data, to justify the solution; and,
3. Full disclosure of any third party intellectual property used in the solution.
References
American Cancer Society, www.americancancersociety.org
en.wikipedia.org/ pancreatic cancer
Pancreatic cancer action network.ww.pancan.org
Memorial sloan kittering cancer center www.mskcc.org/
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