Clinical trial · Interventional
Predictive Value of microRNA in Thyroid Cytologies of Undetermined Type
Study of the Predictive Value of a Signature of microRNA in Thyroid Cytologies of Undetermined Type
NCT04285476CI-TRIAL-00113703PREDICYTHYactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
The aim is to validate a signature of microRNA (micro Ribonucleic acid) based in a first exploratory study allowing the stratification of the cytologies of indeterminate type and to study and select others. In a first step, the teams will focus on standardising the pre-analytical stages and defining a threshold of positivity. The results of microRNA signature on a cohort of 70 patients will be compared with the ultrasound and then histological data of the resection specimen.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Signature of microRNA for patients with bethesda classification 3, 4 or 5 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Signature of microRNA
- description
- Signature of miRNA in patients with Thyroid Cytologies of undetermined type and with a Bethesda classification 3, 4 or 5
- interventionNames
- Diagnostic Test: Signature of microRNA for patients with bethesda classification 3, 4 or 5
Primary outcomes (1)
- measure
- Area under receiver operating characteristic (ROC) curve of the microRNA signature
- timeFrame
- 24 months
Secondary outcomes (4)
- measure
- Sensitivity of the test (microRNA)
- timeFrame
- 24 months
- description
- Sensitivity is defined as the proportion of patients with a malignant nodule (diagnosed by the gold standard method) and a positive test with miRNA signature.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Man or woman whose Age is ≥ 18 years 2. Patient requiring ultrasound for thyroid nodule scanning with established indication of FNAC 3. Patient with Bethesda 3, 4 and 5 thyroid nodule 4. Informed patient and signed informed consent received 5. Patient affiliated to a French medical coverage system Exclusion Criteria: 1. Patient under guardianship, curatorship or safeguarding of justice 2. Patient whose medical or psychological conditions do not permit them to complete the study or to sign the consent, 3. Patient with metastatic cancer distinct from thyroid cancer 4. Patient who has stopped treatment (chemotherapy / immunotherapy) for cancer for less than 6 months.
References
Publications (16)
- BACKGROUNDJacques C, Guillotin D, Fontaine JF, Franc B, Mirebeau-Prunier D, Fleury A, Malthiery Y, Savagner F. DNA microarray and miRNA analyses reinforce the classification of follicular thyroid tumors. J Clin Endocrinol Metab. 2013 May;98(5):E981-9. doi: 10.1210/jc.2012-4006. Epub 2013 Apr 8. PMID 23569218
- BACKGROUNDRuss G, Bonnema SJ, Erdogan MF, Durante C, Ngu R, Leenhardt L. European Thyroid Association Guidelines for Ultrasound Malignancy Risk Stratification of Thyroid Nodules in Adults: The EU-TIRADS. Eur Thyroid J. 2017 Sep;6(5):225-237. doi: 10.1159/000478927. Epub 2017 Aug 8. PMID 29167761
- BACKGROUNDPaschke R, Cantara S, Crescenzi A, Jarzab B, Musholt TJ, Sobrinho Simoes M. European Thyroid Association Guidelines regarding Thyroid Nodule Molecular Fine-Needle Aspiration Cytology Diagnostics. Eur Thyroid J. 2017 Jul;6(3):115-129. doi: 10.1159/000468519. Epub 2017 May 19. PMID 28785538
- BACKGROUNDCantara S, Marzocchi C, Pilli T, Cardinale S, Forleo R, Castagna MG, Pacini F. Molecular Signature of Indeterminate Thyroid Lesions: Current Methods to Improve Fine Needle Aspiration Cytology (FNAC) Diagnosis. Int J Mol Sci. 2017 Apr 6;18(4):775. doi: 10.3390/ijms18040775. PMID 28383480
- BACKGROUNDSahli ZT, Smith PW, Umbricht CB, Zeiger MA. Preoperative Molecular Markers in Thyroid Nodules. Front Endocrinol (Lausanne). 2018 Apr 18;9:179. doi: 10.3389/fendo.2018.00179. eCollection 2018. PMID 29720964
- BACKGROUNDDedhia PH, Rubio GA, Cohen MS, Miller BS, Gauger PG, Hughes DT. Potential effects of molecular testing of indeterminate thyroid nodule fine needle aspiration biopsy on thyroidectomy volume. World J Surg. 2014 Mar;38(3):634-8. doi: 10.1007/s00268-013-2430-x. PMID 24435929
- BACKGROUNDNikiforov YE, Seethala RR, Tallini G, Baloch ZW, Basolo F, Thompson LD, Barletta JA, Wenig BM, Al Ghuzlan A, Kakudo K, Giordano TJ, Alves VA, Khanafshar E, Asa SL, El-Naggar AK, Gooding WE, Hodak SP, Lloyd RV, Maytal G, Mete O, Nikiforova MN, Nose V, Papotti M, Poller DN, Sadow PM, Tischler AS, Tuttle RM, Wall KB, LiVolsi VA, Randolph GW, Ghossein RA. Nomenclature Revision for Encapsulated Follicular Variant of Papillary Thyroid Carcinoma: A Paradigm Shift to Reduce Overtreatment of Indolent Tumors. JAMA Oncol. 2016 Aug 1;2(8):1023-9. doi: 10.1001/jamaoncol.2016.0386.