The Clinical Utility of a Novel Blood-Based Multi-Transcriptome Assay for the Diagnosis of Neuroendocrine Tumors of the Gastrointestinal Tract

Modlin, Irvin M.; Kidd, Mark; Bodei, Lisa; Drozdov, Ignat; Aslanian, Harry R.

doi:10.1038/ajg.2015.160

Cited by 79 publications

(74 citation statements)

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“…The primary outcome was obtaining the NETest score of the patients in the 3 various pNET groups as specified above and the control group. A NETest score between 0% and 100% was obtained and a value of >20% was considered as a positive test . Scores ranging between 0% and 20% were considered as negative.…”

Section: Methodsmentioning

confidence: 99%

“…The term liquid biopsy has been coined to describe the technique of detecting a tumor in blood and has been effectively used in other cancers including breast and colon . Recently, a liquid biopsy strategy for neuroendocrine tumors has been described . It comprises a multianalyte polymerase chain reaction–based blood test specific for neuroendocrine tumors (the NETest) with a sensitivity and specificity of >93% for diagnosis .…”

Section: Introductionmentioning

confidence: 99%

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Measurement of circulating transcript levels (NETest) to detect disease recurrence and improve follow‐up after curative surgical resection of well‐differentiated pancreatic neuroendocrine tumors

Genc

Jilesen

Dijkum

et al. 2018

Journal of Surgical Oncology

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Measurement of circulating transcript levels (NETest) to detect disease recurrence and improve follow‐up after curative surgical resection of well‐differentiated pancreatic neuroendocrine tumors

Genc

Jilesen

Dijkum

et al. 2018

Journal of Surgical Oncology

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“…Multianalyte algorithm analysis strategies based upon a 51-gene signature (NETest) have been reported in NETs [24,26,28,29,51,52,53]. This defines the circulating NET ‘fingerprint' [54] and exhibits a higher sensitivity and specificity (98 and 97%, respectively) than secretory markers for identifying neoplasia [25,51].…”

Section: Discussionmentioning

confidence: 99%

“…This defines the circulating NET ‘fingerprint' [54] and exhibits a higher sensitivity and specificity (98 and 97%, respectively) than secretory markers for identifying neoplasia [25,51]. The assay is standardized and highly reproducible (inter- and intra-assay coefficient of variation <2%), and is independent of tumor heterogeneity [28].…”

Section: Discussionmentioning

confidence: 99%

NET Blood Transcript Analysis Defines the Crossing of the Clinical Rubicon: When Stable Disease Becomes Progressive

et al. 2016

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Background/Aims: A key issue in gastroenteropancreatic neuroendocrine tumors (GEP-NETs) is early identification and prediction of disease progression. Clinical evaluation and imaging are limited due to the lack of sensitivity and disease indolence. We assessed the NETest as a predictive and prognostic marker of progression in a long-term follow-up study. Methods: GEP-NETs (n = 34) followed for a median 4 years (2.2-5.4) were evaluated. WHO tumor grade/stage grade 1: n = 17, grade 2: n = 14, grade 3: n = 1 (for 2, no grade was available); 31 (91%) were stage IV. Baseline and longitudinal imaging and blood biomarkers were available in all, and progression was defined per standard clinical protocols (RECIST 1.0). The NETest was measured by quantitative PCR of blood and multianalyte algorithmic analysis (disease activity scaled 0-100% with low <40% and high activity risk cutoffs >80%); chromogranin A (CgA) was measured by radioimmunoassay (normal <150 µg/l); progression-free survival (PFS) was analyzed by Cox proportional-hazard regression and Kaplan-Meier analysis. Results: At baseline, 100% were NETest positive, and CgA was elevated in 50%. The only baseline variable (Cox modeling) associated with PFS was NETest (hazard ratio = 1.022, 95% confidence interval = 1.005-1.04; p < 0.012). Using Kaplan-Meier analyses, the baseline NETest (>80%) was significantly associated (p = 0.01) with disease progression (median PFS 0.68 vs. 2.78 years with <40% levels). The NETest was more informative (96%) than CgA changes (>25%) in consistently predicting disease alterations (40%, p < 2 × 10^-5, χ² = 18). The NETest had an earlier time point change than imaging (1.02 ± 0.15 years). Baseline NETest levels >40% in stable disease were 100% prognostic of disease progression versus CgA (χ² = 5, p < 0.03). Baseline NETest values <40% accurately (100%) predicted stability over 5 years (p = 0.05, χ² = 3.8 vs. CgA). Conclusion: The NETest correlated with a well-differentiated GEP-NET clinical status. The NETest has predictive and prognostic utility for GEP-NETs identifying clinically actionable alterations ∼1 year before image-based evidence of progression.

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“…Previously, Modlin and coworkers introduced a new PCR-based blood-based multianalyte neuroendocrine gene transcript assay (NETest) for the diagnosis of gastroenteropancreatic neuroendocrine neoplasia (GEP-NEN) (Modlin et al 2015). The NETest comprises 51 multigene transcripts (Modlin et al 2014a).…”

Section: Tumor Markersmentioning

confidence: 99%

The future: diagnostic and imaging advances in MEN1 therapeutic approaches and management strategies

Manoharan¹,

Albers²,

Bartsch³

2017

Endocrine-Related Cancer

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Prospective randomized data are lacking, but current clinical expert guidelines recommend annual screening examinations, including laboratory assessments and various imaging modalities (e.g. CT, MRI, scintigraphy and EUS) for patients with multiple endocrine neoplasia type 1 (MEN1). Routine screening is proposed to detect and localize neuroendocrine manifestations as early as possible. The goal is timely intervention to improve quality of life and to increase life expectancy by preventing the development of life-threatening hormonal syndromes and/or metastatic disease. In recent years, some studies compared different and new imaging methods regarding their sensitivity and utility in MEN1 patients. This present article reviews the proposed diagnostic tools for MEN1 screening as well as potential future perspectives.

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The Clinical Utility of a Novel Blood-Based Multi-Transcriptome Assay for the Diagnosis of Neuroendocrine Tumors of the Gastrointestinal Tract

Abstract: This study demonstrates that a blood-based multianalyte NET gene transcript measurement of well-differentiated small intestinal and pancreatic neuroendocrine tumor disease is sensitive and specific and outperforms the current monoanalyte diagnostic strategy of plasma CgA measurement.

Cited by 79 publications

References 50 publications

Measurement of circulating transcript levels (NETest) to detect disease recurrence and improve follow‐up after curative surgical resection of well‐differentiated pancreatic neuroendocrine tumors

Measurement of circulating transcript levels (NETest) to detect disease recurrence and improve follow‐up after curative surgical resection of well‐differentiated pancreatic neuroendocrine tumors

NET Blood Transcript Analysis Defines the Crossing of the Clinical Rubicon: When Stable Disease Becomes Progressive

The future: diagnostic and imaging advances in MEN1 therapeutic approaches and management strategies

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