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Clinical Laboratories and Pathology Groups
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University of Pittsburgh Pathologists Create World Tumor Registry to Assist Medical Professionals in the Identification and Diagnosis of Cancers

May 24, 2024 | Clinical Laboratory Middleware, Informatics, Analytics, Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Resources, Laboratory Testing

As the cancer registry expands it will increasing become more useful to anatomic pathologists, histopathologists, oncologists, and even clinical laboratories

Oncologists, histopathologists, anatomic pathologists, and other cancer physicians now have a powerful new Wikipedia-style tumor registry to help them with their diagnoses and in educating patients on their specific types of cancer. Clinical laboratory managers may find it useful to understand the value this searchable database, and it can help their staff pathologists as well.

Free to use by both physicians and patients the World Tumor Registry (WTR) is designed “to minimize diagnostic errors by giving doctors a searchable online database of cancers that have been collected and categorized with cellular images collected from around the world,” Pittsburg-Post Gazette reported.

Prompt, accurate cancer diagnoses offer cancer patients the best chance for optimal treatment outcomes. However, many medical professionals around the globe do not have the training and resources to offer superior cancer diagnoses. That deficiency can translate to inferior treatment options and lower survival rates among cancer patients. 

To help improve cancer diagnoses, pathologist Yuri E. Nikiforov, MD, PhD, Division Director, Molecular and Genomic Pathology, Vice Chair of the Department of Pathology,  and Professor of Pathology, University of Pittsburgh, developed the WTR to provide educational and practical resources for individuals and organizations involved in cancer research.

Officially announced at the United States and Canadian Academy of Pathology (USCAP) annual convention, the WTR is an open-access catalog of digital microscopic images of human cancer types and subtypes.

The lower cost of technology and improved speed of access via the internet are technologies enabling this effort.

“We are creating sort of a Wikipedia for cancer images,” said Alyaksandr V. Nikitski, MD, PhD (above), Research Assistant Professor of Pathology, Division of Molecular and Genomic Pathology at Pittsburg School of Medicine and Administrative Director of the WTR, in an exclusive interview with Dark Daily. “Anyone in the world, if they can access the internet, can look at the well-annotated, diagnostic digital slides of cancer,” said Nikitski. Clinical laboratories may also find this new pathology tool useful. (Photo copyright: Alyaksandr V. Nikitski)

Minimizing Diagnostic Errors

Based in Pittsburgh, the WTR is freely available to anyone for viewing digital pathology slides of known cancer tumors as well as borderline and questionable cases. On the website, individuals can search for pictures of tumors in the registry by diagnosis, specific cohorts, and by microscopic features. Individuals may search further by tumor type and subtype to receive a picture of related tumors. 

According to the WTR website, the mission of the nonprofit “is to minimize diagnostic errors, eliminate inequality in cancer recognition, diagnosis, and treatment in diverse populations, and improve outcomes by increasing access to the diagnostic pathology expertise and knowledge of microscopic characteristics of cancers that occur in different geographic, environmental, and socio-economic settings.”

This new comprehensive initiative will eventually encompass cancer images from all over the world. 

“Let’s assume that I am a pathologist or a trainee who has little experience, or I don’t have access to collections of atypical tumors,” Nikitski explained. “I can view tumor collections online [in the WTR database] and check how typical and rare tumors look in various geographic regions and environmental settings.”

Once an image of a slide is selected, users will then receive a brief case history of the tumor in addition to such data as the age of the patient, their geographic location, sex, family history of the disease, and the size and stage of the tumor.

Increasing Probability of Correct Diagnosis

Pathologists and clinicians may also predict the probability of a particular diagnosis by searching under the microscopic feature of the database. This feature utilizes an innovative classifier known as PathDxFinder, where users may compare a slide from their lab to slides in the database by certain criteria. This includes:

After completing the questions above, the user presses the “predict diagnosis” button to receive the probability of cancer and most likely diagnosis based on the answers provided in the questionnaire.

WTR Editorial Boards

The WTR represents collections for each type of cancer site, such as lung or breast. A chairperson and editorial board are responsible for reviewing submitted slides before they are placed online. The editorial boards include 20 pathologists who are experts in diagnosing cancer categories, Nikitski explained.

Thousands of identified microscopic whole slide images (WSI) representing various types of cancer are deposited by the editors and other contributors to the project. The editorial board then carefully analyzes and compiles the data before posting the images for public viewing. 

The editorial boards are located in five world regions:

  • Africa and the Middle East
  • Asia and Oceania
  • Central and South America
  • North America and Europe
  • Northern Asia

Any physicians or pathologists can contribute images to the database, by “simply selecting the editor of their region on the website, writing their name, and asking if they can submit tumor cases,” Nikitski stated.

“We have established a platform that allows pathologists to contact editors who are in the same geographic region,” he added.

Helping Physicians Identify Cancer Types 

In a YouTube video, Nikiforov states that the WTR is an “educational nonprofit organization rooted in [the] beliefs that every cancer patient deserves accurate and timely diagnosis as the first and essential step in better treatment and outcomes.”

“We believe this can be achieved only when modern diagnostic tools and technologies are freely available to every physician and pathologist. Only when we understand how microscopic features of cancer vary in different geographic, environmental and ethnic populations, and only by integrating histopathology with clinical immunohistochemical and molecular genetic information for every cancer type,” he stated.

Since patient privacy is important, the database contains only basic data about patients, and all patient information is protected.

Launched in March, there are currently more than 400 thyroid tumor slides available to view in the online database. At the time of the announcement, the WTR platform was planned to be implemented in three phases:

  • Thyroid cancer (released in March of this year).
  • Lung cancer and breast cancer (anticipated to be completed by the third quarter of 2026).
  • Remaining cancers, including brain, soft tissue and bone, colorectal, head and neck, hematolymphoid, female genital, liver, pancreatic, prostate and male genital, skin, urinary system, pediatric, other endocrine cancers, and rare cancers (anticipated to be completed by the end of 2029).

“We believe that this resource will help physicians and pathologists practicing in small or big or remote medical centers to learn how cancer looks under a microscope in their own communities,” Nikiforov said in the video. “We also see WTR as a platform that connects physicians and scientists from different parts of the world who can work together to better understand and treat cancer.”

Catalogs like the World Tumor Registry might potentially create a pool of information that that could be mined by analytical and artificial intelligence (AI) platforms to ferret out new ways to improve the diagnosis of certain types of cancer and even enable earlier diagnoses. 

“It is an extremely useful resource,” Nikitski said.

Anatomic pathologists will certainly find it so. And clinical laboratory managers may find the information useful as well when interacting with histopathologists and oncologists. 

—JP Schlingman

Related Information:

“Free for the World:” Pittsburgh Pathologist Prepares to Launch a Wikipedia for Cancer

USCAP 113th Annual Meeting

World Tumor Registry

Video: Message from the Founder and President of the World Tumor Registry

NIH Scientists Develop New Clinical Laboratory Assay to Measure Effectiveness of ‘Good’ Cholesterol

May 22, 2024 | Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Resources, Laboratory Testing

Clinical studies show that new ‘cell-free’ test can predict cardiovascular disease risk better than standard HDL cholesterol test

Researchers from the National Institutes of Health (NIH) have developed a diagnostic assay that measures how well high-density lipoprotein (HDL)—the so-called “good” cholesterol—is working in the body. And their findings could lead to new clinical laboratory tests that supplement standard HDL level testing to better determine a person’s risk for heart disease.

Cholesterol tests are among the most commonly performed assays by clinical laboratories. A new test that reveals how well HDL is working in the body would certainly boost a medical laboratory’s test requisition volume.

The researchers are with the NIH’s National Heart, Lung, and Blood Institute (NHLBI).

“Measuring HDL function is limited to research labs and isn’t conducive to large-scale testing by routine clinical laboratories. To try to solve that problem, researchers from NHLBI’s Lipoprotein Metabolism Laboratory created a new diagnostic test,” noted an NHLBI news release.

“This is going to quicken the pace of basic research,” said Edward B. Neufeld, PhD, who along with guest researcher Masaki Sato, PhD, developed the test. “It increases the number of samples that you can study. It increases the number of experiments you can do.”

The researchers published their findings in The Journal of Clinical Investigation titled, “Cell-Free, High-Density Lipoprotein–Specific Phospholipid Efflux Assay Predicts Incident Cardiovascular Disease.” They have also patented their test and plan to work with a company on licensing and manufacturing it.

Such a new cholesterol test would quickly become one of the most commonly performed clinical lab tests because just about every American who has a physical gets cholesterol tests as part of that process.

“Other people may modify this or come up with better versions, which is fine with us,” Edward Neufeld, PhD (above), NHLBI Staff Scientist, said in a news release. “We just really wanted to tackle this problem of evaluating HDL function.” Clinical laboratories may soon have a new cholesterol test to supplement standard HDL level testing. (Photo copyright: ResearchGate.)

Faster Answers Needed about HDL 

According to the NIH, the goal should go beyond measuring level of HDL as part of a person’s annual physical. What is also needed is finding out whether HDL cholesterol is effectively doing certain tasks, such as removing extra cholesterol from arteries and transporting it to the liver.

The NHLBI’s new cell-free test may make it possible to step up large-scale clinical testing of HDL function, according to the news release. As it stands now, HDL function study has been limited to research labs where testing involves “harvesting cells in the lab [which] can take days to process,” according to NIH Record.

“Most studies to date that have assessed CAD (coronary artery disease) risk by HDL functionality still use the CEC (cellular cholesterol efflux capacity) in vitro assay and are based on the use of radioisotopes (3H-cholesterol) and cultured cells, which is very labor intensive and impractical to do in a clinical laboratory,” the researchers wrote in The Journal of Clinical Investigation. They also pointed out that CEC batch-to-batch variability does not fit clinical laboratories’ need for standardization.

Advantages of NHLBI’s Test  

To overcome these barriers, the NHLBI researchers created an HDL-specific phospholipid efflux (HDL-SPE) assay that has certain advantages over current HDL function assessments done in research labs.

According to the NIH, the HDP-SPE assay:

  • Is easy to replicate in clinical labs.
  • Is more suited to automation and large samples.
  • Offers up results in about an hour.
  • Is a better predictor of cardiovascular disease risk than HDL cholesterol testing for CAD risk.

“We developed a cell-free, HDL-specific phospholipid efflux assay for the assessment of CAD risk on the basis of HDL functionality in whole plasma or serum. One of the main advantages of the HDL-SPE assay is that it can be readily automated, unlike the various CEC assays currently in use,” the authors noted in their paper.

Here is how the test is performed, according to the NIH:

  • Plasma with HDL is separated from the patient’s blood.
  • “Plasma is added to donor particles coated with a lipid mixture resembling plaque and a fluorescent-tagged phospholipid” that only HDL can remove.
  • The fluorescent signal by HDL is then measured.
  • A bright signal suggests optimal HDL lipid removal function, while a dim light means reduced function.

The test builds on the scientists’ previous findings and data. In creating the new assay they drew on data from:

  • A study of 50 severe CAD and 50 non-CAD people.
  • A Japanese study of 70 CAD and 154 non-CAD participants.
  • Examined association of HDL-SPE with cardiovascular disease in a study of 340 patients and 340 controls.

“We have established the HDL-SPE assay for assessment of the functional ability of HDL to efflux phospholipids. Our combined data consistently show that our relatively simple HDL-SPE assay captures a pathophysiologically relevant parameter of HDL function that is at least equivalent to the CEC assay in its association with prevalent and incident CAD,” the researchers concluded in The Journal of Clinical Investigation. 

Test May Be Subject to New FDA Rule

While HDL cardiovascular-related research is moving forward, studies aimed at the therapeutic side need to pick up, NIH noted.

“Someday we may have a drug that modulates HDL and turns out to be beneficial, but right now we don’t have that,” said Alan Remaley MD, PhD, NHLBI Senior Investigator and Head of the Lipoprotein Metabolism Laboratory, in the news release.

It may be years before the HDL-SPE test is used in medical settings, the researchers acknowledged, adding that more studies are needed with inclusion of different ethnicities.

Additionally, in light of the recently released US Food and Drug Administration (FDA) final rule on regulation of laboratory developed tests (LDT), the company licensed to bring the test to market may need to submit the HDL-SPE assay to the FDA for premarket review and clearance. That could lengthen the time required for the developers to comply with the FDA before the test is used by doctors and clinical laboratories in patient care.

—Donna Marie Pocius

Related Information:

FDA Takes Action Aimed at Helping Ensure Safety and Effectiveness of Laboratory Developed Tests

Cell-free, High-Density Lipoprotein-Specific Phospholipid Efflux Assay Predicts Incident Cardiovascular Disease

An Updated Test Measures How Well “Good Cholesterol” Works

NHLBI Refines Test for Good Cholesterol Function

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