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Final study results support the use of screening

Final study results support the use of screening

 


Blood tests for early detection of cancer: final study results support the use of screening

A table showing the sensitivity of tests to detect cancer by clinical stage. Credit: Annals of Oncology

The final results of a blood test that can detect more than 50 types of cancer show that it is accurate enough to be deployed as a multicancer screening among people at high risk of disease, including patients aged 50 years. , No symptoms.

In a treatise published in a major cancer journal Annual Tumor Report Today, researchers report that while the false positive rate is very low, the test often detected the cancer accurately before the onset of symptoms. This test accurately predicted where the cancer was in the body. This helps doctors choose effective diagnostic tests.

GRAIL, Inc., which develops and funds research. (California, USA) is currently making early detection of multiple cancers available on a prescription basis in the United States, complementing other existing screening methods, including breast screening methods. Cervical cancer, prostate cancer, lung cancer, intestinal cancer. Many cancers that can be detected by the test, such as liver cancer, pancreatic cancer, and esophageal cancer, do not have screening tests. These are the most deadly and early detection can make a real difference.

The lead author of this paper, Dr. Eric Klein, Chairman of the Glickman Urological and Kidney Institute at the Cleveland Clinic in Cleveland, USA, said: These data show that when used in combination with existing screening tests, multiple cancer detection tests can have a significant impact on how cancer is detected and, ultimately, how it is detected. Suggests. .. “

This test takes a sample of blood from each patient and analyzes the DNA that the tumor (and other cells) releases into the blood, called cell-free DNA (cfDNA). Genome sequencing is used to detect chemical changes in DNA called “methylation” that control gene expression, and machine learning (artificial intelligence) -developed classifiers use these results to use these results. Detects abnormal methylation patterns that suggest the presence of cancer.in addition Classifiers can predict where the cancer is in the body. Results will be available within 10 business days of the sample arriving in the lab.

The third and final substudy of the Circulating Cell-free Genome Atlas (CCGA) study reported today examined the performance of tests in 2,823 people who had already been diagnosed with cancer and 1,254 people without cancer. Detects cancer signals from more than 50 types of cancer and determines when 51.5% of cancers are present (sensitivity or true positive rate) in all four cancer stages (I, II, III, IV) Tests have shown that it can be identified correctly. Case. The test specificity (true negative rate) was 99.5%. This means that only 0.5% of the tests falsely detected cancer (false positive rate).

The sensitivity of the test is 12 pre-designated cancers (anal, bladder, intestine, esophagus, stomach, head and neck, liver, and bile ducts, lungs, ovaries and pancreas, which account for two-thirds of cancer deaths each year in the United States. Cancer, lymphoma, and leukocyte cancers such as multiple myeloma), with more than 50 cancers totaling 40.7%.

For all cancers, detection was improved at each cancer stage, with sensitivities of 16.8% for early stage I, 40.4% for stage II, 77% for stage III, and 90.1% for stage IV. This is the most advanced stage of frequent symptoms. ..

Sensitivity depends on the type of cancer. For solid tumors without screening options such as esophageal cancer, liver cancer, and pancreatic cancer, the overall sensitivity of the test is solid with screening options such as breast, bowel, cervical, and prostate cancer. It was twice as large as the tumor: 65.6% compared to 33.7%. The overall sensitivity of hematological malignancies such as lymphoma and myeloma was 55.1%.

In addition, the early detection test for multiple cancers correctly identified the tissue in which the cancer is present in 88.7% of cases.

Dr. Klein said: “We believe that cancers that release more cfDNA into the bloodstream are easier to detect. These cancers are also likely to be fatal, and previous studies have shown that this multicancer early detection test It has been shown to detect these types of cancer more strongly. Cancers such as the prostate release less DNA than other tumors, so existing screening tests are still important for these cancers. “

To understand how the test would be performed when used to screen a population, researchers found that the positive predictive value (PPV) (a positive result that was correctly identified as cancer). Percentage of) and the negative predictive value (NPV) were estimated. )-Correctly identified as having no cancer. People aged 50-79 years, who are most likely to develop cancer, had a PPV of 44.4% and an NPV of 99.4%.

Dr. Klein concludes: “These data are increasing the literature supporting the use of next-generation sequencing to detect cell-free DNA in blood samples as a tool for early detection of a significant number of common cancers. In addition, screening tests that require only simple blood sampling may provide options for communities with inadequate access to medical facilities. The potential impact of this approach on public health. I am excited. .”

Researchers continue to collect additional data from tests in large prospective studies in the United States (STRIVE, PATHFINDER, and REFLECTION studies) and the United Kingdom (SUMMIT studies) to explore the feasibility of population screening. GRAIL has also established a partnership with the United Kingdom National Health Service to investigate the clinical and economic performance of early detection of multiple cancers in approximately 165,000 eligible patients since the second half of this year.

The strength of the CCGA study as a whole is that it includes a total of 15,254 participants from 142 clinics in North America, which helps to generalize the results to diverse populations. Participants in this final sub-study were not included in the early development phase of the test to ensure an accurate estimate of performance. The limits of this substudy are: If blood samples are taken from a cancer patient after undergoing a biopsy, this may increase the proportion of cfDNA in the blood compared to before the biopsy. CCGA is a case-control study, Performed in population screening conditions (which has been evaluated in the PATHFINDER study). In addition, inaccuracies have occurred in the detection of cancer-derived tissues of cancers caused by human papillomavirus (HPV), such as cervical cancer, anal cancer, and head and neck cancer.

Editor-in-chief Annual Tumor ReportProfessor Fabrice André, Principal Investigator of Institut Gustave Roussy in Villejuif, France, said: Study as it can save the lives of millions of people around the world. The first step is to develop a technology that addresses this issue. The next step involves the development of new therapeutic interventions. At the same time, major efforts related to artificial consciousness need to be continued. Otherwise, not all of these efforts will transform the outcome. ”


Blood tests detect a wide range of cancers available to individuals at risk in clinical research


For more information:
EA Klein et al, Clinical Validation of Targeted Methylation-Based Multicancer Early Detection Tests Using Independent Validation Set, Annual Tumor Report (2021). DOI: 10.1016 / j.annonc.2021.05.806

Quote: Blood test for early detection of cancer: Final study results were obtained from https://medicalxpress.com/news/2021-06-blood-early-cancer-results-screening on June 25, 2021. Supports the use of screening (June 25, 2021). html

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