Evidence map›Paper›PMID 27798083›Full record

ArticleJournal of clinical pathology2017

Multicentre validation of a microRNA-based assay for diagnosing indeterminate thyroid nodules utilising fine needle aspirate smears.

Gila Lithwick-Yanai, Nir Dromi, Alexander Shtabsky, Sara Morgenstern, Yulia Strenov, Meora Feinmesser, Vladimir Kravtsov, Marino E Leon, Marián Hajdúch, Syed Z Ali and 24 more

Registry-linked trialAbstract readMulticenter StudyValidation Study
In one paragraph

Article in Journal of clinical pathology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04285476 (Study of the Predictive Value of a Signature of microRNA in Thyroid Cytologies of Undetermined Type), which is not on this map. Cited by 58 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04285476 naactive not recruitingnot on this mapstarted 2021, after this paper: background citation

Study of the Predictive Value of a Signature of microRNA in Thyroid Cytologies of Undetermined Type

TypeinterventionalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2021 to 2026Enrolled71ConditionsThyroid CancerArmsSignature of microRNA for patients with bethesda classification 3, 4 or 5
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review: Detection of Cancer Biomarkers from a Clinical Perspective.International journal of molecular sciences · 2025
    Review
  5. Observational
  6. Article
  7. IsomiR stoichiometry changes as disease biomarkers.Molecular therapy. Nucleic acids · 2025
    Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. miRNA-Based Technologies in Cancer Therapy.Journal of personalized medicine · 2023
    Review
  14. Progress in Thyroid Cancer Genomics: A 40-Year Journey.Thyroid : official journal of the American Thyroid Association · 2023
    Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors.

Gila Lithwick-YanaiRosetta Genomics Ltd, Rehovot, Israel.
Nir DromiRosetta Genomics Ltd, Rehovot, Israel.
Alexander ShtabskyPathology Institute, Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel.
Sara MorgensternThe Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Yulia StrenovThe Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Meora FeinmesserThe Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Vladimir KravtsovThe Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Marino E LeonH. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Marián HajdúchInstitute of Molecular and Translational Medicine, Faculty of Medicine and Dentistry, Palacky University, Olomouc, Czech Republic.
Syed Z AliThe Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Christopher J VandenBusscheThe Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Xinmin ZhangTemple University Hospital, Philadelphia, Pennsylvania, USA.
Leonor Leider-TrejoPathology Institute, Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel.
Asia ZubkovPathology Institute, Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel.
Sergey VorobyovNational Centre of Clinical and Morphological Diagnostics, St Petersburg, Russia.
Michal KushnirRosetta Genomics Ltd, Rehovot, Israel.
Yaron GorenRosetta Genomics Ltd, Rehovot, Israel.
Sarit TabakRosetta Genomics Ltd, Rehovot, Israel.
Etti KadoshRosetta Genomics Ltd, Rehovot, Israel.
Hila BenjaminRosetta Genomics Inc, Philadelphia, Pennsylvania, USA.
Temima Schnitzer-PerlmanRosetta Genomics Ltd, Rehovot, Israel.
Hagai MarmorRosetta Genomics Ltd, Rehovot, Israel.
Maria MotinRosetta Genomics Ltd, Rehovot, Israel.
Danit LebanonyRosetta Genomics Ltd, Rehovot, Israel.
Sharon Kredo-RussoRosetta Genomics Ltd, Rehovot, Israel.
Heather MitchellRosetta Genomics Inc, Philadelphia, Pennsylvania, USA.
Melissa NollerRosetta Genomics Inc, Philadelphia, Pennsylvania, USA.
Alexis SmithRosetta Genomics Inc, Philadelphia, Pennsylvania, USA.
Olivia DattnerRosetta Genomics Inc, Philadelphia, Pennsylvania, USA.
Karin AshkenaziRosetta Genomics Inc, Philadelphia, Pennsylvania, USA.
Mats SandenRosetta Genomics Inc, Philadelphia, Pennsylvania, USA.
Kenneth A BerlinRosetta Genomics Inc, Philadelphia, Pennsylvania, USA.
Dganit BarRosetta Genomics Ltd, Rehovot, Israel.
Eti MeiriRosetta Genomics Ltd, Rehovot, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe distinction between benign and malignant thyroid nodules has important therapeutic implications. Our objective was to develop an assay that could classify indeterminate thyroid nodules as benign or suspicious, using routinely prepared fine needle aspirate (FNA) cytology smears.

methodsA training set of 375 FNA smears was used to develop the microRNA-based assay, which was validated using a blinded, multicentre, retrospective cohort of 201 smears. Final diagnosis of the validation samples was determined based on corresponding surgical specimens, reviewed by the contributing institute pathologist and two independent pathologists. Validation samples were from adult patients (≥18 years) with nodule size >0.5 cm, and a final diagnosis confirmed by at least one of the two blinded, independent pathologists. The developed assay, RosettaGX Reveal, differentiates benign from malignant thyroid nodules, using quantitative RT-PCR.

resultsTest performance on the 189 samples that passed quality control: negative predictive value: 91% (95% CI 84% to 96%); sensitivity: 85% (CI 74% to 93%); specificity: 72% (CI 63% to 79%). Performance for cases in which all three reviewing pathologists were in agreement regarding the final diagnosis (n=150): negative predictive value: 99% (CI 94% to 100%); sensitivity: 98% (CI 87% to 100%); specificity: 78% (CI 69% to 85%).

conclusionsA novel assay utilising microRNA expression in cytology smears was developed. The assay distinguishes benign from malignant thyroid nodules using a single FNA stained smear, and does not require fresh tissue or special collection and shipment conditions. This assay offers a valuable tool for the preoperative classification of thyroid samples with indeterminate cytology.

Indexed as

Biopsy, Fine-NeedleFemaleHumansMaleMicroRNAsMiddle AgedObserver VariationPredictive Value of TestsThyroid NeoplasmsThyroid NoduleMicroRNAsDIAGNOSTICSLABORATORY TESTSMOLECULAR ONCOLOGYTHYROIDTHYROID CANCER

Identifiers

PMID27798083
PMCPMC5484037

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.