47 Pathologists enhance interpretation of automated multiplex immunohistochemistry assays in cancer immunotherapy trials

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A50-A50
Author(s):  
Emmanuel Pacia ◽  
Xun Li ◽  
Ju Young Kim ◽  
Evelyn Diaz ◽  
Beiru Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cancer Immunotherapy ◽  
Tissue Section ◽  
Simultaneous Detection ◽  
Digital Pathology ◽  
B Cell Lymphoma ◽  
Multiple Tumor ◽  
Computer Aided ◽  
Analytical Phase

BackgroundMultiplex fluorescence immunohistochemistry (mFIHC) enables simultaneous detection of multiple biomarkers on a single tissue section. Spatial patterns and differential expression of immune- and tumor cell biomarkers serve as powerful predictors of immunotherapies. In a recent meta-analyses of 8135 patients treated with PD1/L1 pathway blockers, mFIHC was found to provide highest predictive power (P<0.05) amongst commonly utilized biomarker modalities, namely, PD-L1 IHC, Tumor Mutation Burden and Gene Expression Profiling alone. [Lu et al., JAMA Oncol 2019]. As biomarkers in mFIHC assays are read by computer-aided algorithms, the role of pathologists in the digital workflow has been debated. Utilizing clinical cases representing multiple tumor indications, we illustrate the critical collaboration between pathologists (human intelligence, HI) and computer workflows (artificial intelligence, AI) required for accurate interpretation of mFIHC assays in cancer immunotherapy trials.MethodsIn our clinical trial laboratory, pathologists are involved in pre-analytical, analytical and post-analytical phases of clinical trial sample testing. In the pre-analytical phase, pathologist(s) perform histological examination of H&E stained tissue sections to annotate and confirm tissue types, diagnosis, tissue integrity and acceptance (including viable tumor component), followed by determination of Region of Interest (ROI) for subsequent analysis by computerized programs. In the analytical phase, pathologists identify specific areas of biological and/or clinical interest within ROI (tumor, non-tumor, invasive margin, and tumor-stromal interphase) in the computer scans, as well as exclude ROI containing necrosis, hemorrhage, blood vessels, and autofluorescence. Those pathologist-selected images are then quantified by digital pathology software such as Automated QUantitative Analyses (AQUA®) technology. Finally, pathologists also provide interpretation and summarize findings relevant to the clinical study during the post-analytical phase.ResultsCase studies representing distinct malignancies, such as melanoma, non-small cell lung cancer, squamous cell carcinoma of head and neck and diffuse large B-cell lymphoma, illustrating the role of pathologists and especially in rescuing challenging cases and interpreting biomarkers scores from mFIHC assays will be presented.ConclusionsWith the advancement in technologies to detect increasing number of biomarkers in a single tissue section and accompanied growth of mFIHC assays in immuno-oncology studies, there is a clear transition from conventional pathology (HI) to computer-aided pathology (AI+HI) that will ultimately ensure greater accuracy, reproducibility and standardization of clinical trial testing, and enable approval of more effective therapies and better patient care.

Role of convalescent plasma therapy in new Coronavirus disease (nCOVID-19): A review

2020 ◽  
Vol 11 (SPL1) ◽  
pp. 546-549
Author(s):  
Shweta Dadarao Parwe ◽  
Milind Abhimanyu Nisargandha ◽  
Rishikesh Thakre
Keyword(s):  
Clinical Trial ◽  
Immune Responses ◽  
Indian Population ◽  
Preventive Treatment ◽  
The Body ◽  
Therapeutic Antibodies ◽  
Plasma Therapy ◽  
Host Immune Responses ◽  
Transparent Liquid

Hitherto, there is no proper line of treatment for the new (nCOVID19). The development of unique antiviral drugs has taken precedence. Therapeutic antibodies () will be a significantly beneficial agent against nCOVID-19. Here the host immune responses to new discussed in this review provide strategy and further treatment and understanding of clinical interventions against nCOVID-19. Plasma therapy uses the antibodies found in the blood of people recovering (or convalesced) from an infection to treat infected patients. When an infection occurs, the body begins producing proteins specially made to kill the germ, called antibodies. Those antibodies coat specifically plasma in the blood of survivors, the yellow transparent liquid blood portion for months or even years. research assesses plasma use from Convalescent patients of infected with nCOVID-19 as a possible preventive treatment. But it is not yet recommended as a line of treatment, and it is used as a clinical trial in the new in Indian population.

scholarly journals Does intervention with GLP-1 receptor agonist semaglutide modulate perception of sweet taste in women with obesity: study protocol of a randomized, single-blinded, placebo-controlled clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Mojca Jensterle ◽  
Simona Ferjan ◽  
Tadej Battelino ◽  
Jernej Kovač ◽  
Saba Battelino ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neural Response ◽  
Taste Perception ◽  
Taste Bud ◽  
Controlled Clinical Trial ◽  
Food Cues ◽  
Link Type ◽  
Visual Food Cues ◽  
Taste Bud Cells

Abstract Background Preclinical studies demonstrated that glucagon-like peptide 1 (GLP-1) is locally synthesized in taste bud cells and that GLP-1 receptor exists on the gustatory nerves in close proximity to GLP-1-containing taste bud cells. This local paracrine GLP-1 signalling seems to be specifically involved in the perception of sweets. However, the role of GLP-1 in taste perception remains largely unaddressed in clinical studies. Whether any weight-reducing effects of GLP-1 receptor agonists are mediated through the modulation of taste perception is currently unknown. Methods and analysis This is an investigator-initiated, randomized single-blind, placebo-controlled clinical trial. We will enrol 30 women with obesity and polycystic ovary syndrome (PCOS). Participants will be randomized in a 1:1 ratio to either semaglutide 1.0 mg or placebo for 16 weeks. The primary endpoints are alteration of transcriptomic profile of tongue tissue as changes in expression level from baseline to follow-up after 16 weeks of treatment, measured by RNA sequencing, and change in taste sensitivity as detected by chemical gustometry. Secondary endpoints include change in neural response to visual food cues and to sweet-tasting substances as assessed by functional MRI, change in body weight, change in fat mass and change in eating behaviour and food intake. Discussion This is the first study to investigate the role of semaglutide on taste perception, along with a neural response to visual food cues in reward processing regions. The study may identify the tongue and the taste perception as a novel target for GLP-1 receptor agonists. Ethics and disseminations The study has been approved by the Slovene National Medical Ethics Committee and will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be submitted for publication in an international peer-reviewed scientific journal. Trial registration ClinicalTrials.govNCT04263415. Retrospectively registered on 10 February 2020

scholarly journals Application of artificial intelligence in pancreaticobiliary diseases

2021 ◽  
Vol 14 ◽  
pp. 263177452199305
Author(s):  
Hemant Goyal ◽  
Rupinder Mann ◽  
Zainab Gandhi ◽  
Abhilash Perisetti ◽  
Zhongheng Zhang ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
Response To Treatment ◽  
Endoscopic Retrograde ◽  
Artificial Intelligence Techniques ◽  
Computer Aided ◽  
Rapid Pace ◽  
Cystic Pancreatic Lesions ◽  
Aided Diagnosis

The role of artificial intelligence and its applications has been increasing at a rapid pace in the field of gastroenterology. The application of artificial intelligence in gastroenterology ranges from colon cancer screening and characterization of dysplastic and neoplastic polyps to the endoscopic ultrasonographic evaluation of pancreatic diseases. Artificial intelligence has been found to be useful in the evaluation and enhancement of the quality measure for endoscopic retrograde cholangiopancreatography. Similarly, artificial intelligence techniques like artificial neural networks and faster region-based convolution network are showing promising results in early and accurate diagnosis of pancreatic cancer and its differentiation from chronic pancreatitis. Other artificial intelligence techniques like radiomics-based computer-aided diagnosis systems could help to differentiate between various types of cystic pancreatic lesions. Artificial intelligence and computer-aided systems also showing promising results in the diagnosis of cholangiocarcinoma and the prediction of choledocholithiasis. In this review, we discuss the role of artificial intelligence in establishing diagnosis, prognosis, predicting response to treatment, and guiding therapeutics in the pancreaticobiliary system.

scholarly journals Special Issue: The Role of Complement in Cancer Immunotherapy

Antibodies ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 29
Author(s):  
Ronald P. Taylor
Keyword(s):  
Cancer Immunotherapy ◽  
Complement System ◽  
Immune Defense ◽  
Special Issue ◽  
The Complement System ◽  
Critical Aspects

The complement system plays an important role in critical aspects of immune defense and in the maintenance of homeostasis in the bloodstream, as well as in essentially all tissues and organs [...]

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