タイプ未確定の甲状腺細胞診におけるマイクロRNAの予測値 (PREDICYTHY)
タイプ未定の甲状腺細胞診におけるマイクロRNAの特徴の予測値に関する研究
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Morphological analysis of fine-needle aspiration cytology (FNAC) under ultrasound classifies thyroid nodules in 6 categories (Bethesda classification). The diagnostic approach is codified by the Society of Endocrinology and for cytologies of indeterminate type (Bethesda 3, 4 and 5), surgery of thyroid nodules is currently recommended. However, only 15.9% of the cytologies classified Bethesda 3, 26.1% of the Bethesda IV and 75.2% of the Bethesda V are actually cancers in the definitive histological analysis on surgical resection.
Thus, new tools for predicting the risk of thyroid nodule malignancy need to be developed.
To date, various risk stratification biomarkers have been reported in the literature but have not been validated in independent cohorts, thus excluding their implementation in daily practice.
In addition, two commercial nucleic acid tests are proposed at a cost not compatible with generalized diffusion. The first approach is based on a next generation sequencing analysis of a target gene panel at the nucleotide sequence or transcribed level. The second alternative combines an analysis at level 1) of the deoxyribonucleic acid (DNA) with the search for somatic variations such as mutations in oncogenes or the presence of fusion genes, and 2) microRNA with the measurement of their level of expression.
Due to their stability, their ability to modulate the expression of various messenger RNA, microRNA are an attractive line of research.
The aim is to validate a signature of microRNA 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.
研究の種類
研究の種類
入学 (実際)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
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-
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Nîmes、フランス、30029
- CHU de Nîmes
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-
Haute-Garonne
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Toulouse、Haute-Garonne、フランス、31000
- CHU de Toulouse
-
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Hérault
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Montpellier、Hérault、フランス、34298
- Institut régional du Cancer de Montpellier
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-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Man or woman whose Age is ≥ 18 years
- Patient requiring ultrasound for thyroid nodule scanning with established indication of FNAC
- Patient with Bethesda 3, 4 and 5 thyroid nodule
- Informed patient and signed informed consent received
- Patient affiliated to a French medical coverage system
Exclusion Criteria:
- Patient under guardianship, curatorship or safeguarding of justice
- Patient whose medical or psychological conditions do not permit them to complete the study or to sign the consent,
- Patient with metastatic cancer distinct from thyroid cancer
- Patient who has stopped treatment (chemotherapy / immunotherapy) for cancer for less than 6 months.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：Signature of microRNA
Signature of miRNA in patients with Thyroid Cytologies of undetermined type and with a Bethesda classification 3, 4 or 5 |
If the cytology results are Bethesda 3, 4 or 5, then a miRNA analysis will be performed. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
マイクロRNAシグネチャの受信者動作特性（ROC）曲線下の面積
時間枠：24ヶ月
|
24ヶ月
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sensitivity of the test (microRNA)
時間枠：24 months
|
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. |
24 months
|
|
Specificity of the test (microRNA)
時間枠：24 months
|
The specificity of the test is defined as the proportion of patients with a benign nodule (diagnosed by the gold standard method) and a negative test with miRNA signature. |
24 months
|
|
Positive predictive value (PPV) of the test (microRNA)
時間枠：24 months
|
The positive predictive value is defined as the probability that the patient with a positive test is actually affected by a malignant nodule (diagnosed by the gold standard method). |
24 months
|
|
Negative predictive value (NPV) of the test (microRNA)
時間枠：24 months
|
The negative predictive value is defined as the probability that the patient with a negative test is actually affected by a benign nodule (diagnosed by the gold standard method). |
24 months
|
協力者と研究者
捜査官
捜査官
- スタディチェア：Thierry GALVEZ, MD、Institut régional du Cancer de Montpellier
出版物と役立つリンク
一般刊行物
- Russ 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.
- Jacques 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.
- Paschke 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.
- Cantara 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.
- Sahli 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.
- Dedhia 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.
- Nikiforov 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.
- Faquin WC, Wong LQ, Afrogheh AH, Ali SZ, Bishop JA, Bongiovanni M, Pusztaszeri MP, VandenBussche CJ, Gourmaud J, Vaickus LJ, Baloch ZW. Impact of reclassifying noninvasive follicular variant of papillary thyroid carcinoma on the risk of malignancy in The Bethesda System for Reporting Thyroid Cytopathology. Cancer Cytopathol. 2016 Mar;124(3):181-7. doi: 10.1002/cncy.21631. Epub 2015 Oct 12.
- Paulson VA, Shivdasani P, Angell TE, Cibas ES, Krane JF, Lindeman NI, Alexander EK, Barletta JA. Noninvasive Follicular Thyroid Neoplasm with Papillary-Like Nuclear Features Accounts for More Than Half of "Carcinomas" Harboring RAS Mutations. Thyroid. 2017 Apr;27(4):506-511. doi: 10.1089/thy.2016.0583. Epub 2017 Feb 24.
- Strickland KC, Howitt BE, Marqusee E, Alexander EK, Cibas ES, Krane JF, Barletta JA. The Impact of Noninvasive Follicular Variant of Papillary Thyroid Carcinoma on Rates of Malignancy for Fine-Needle Aspiration Diagnostic Categories. Thyroid. 2015 Sep;25(9):987-92. doi: 10.1089/thy.2014.0612. Epub 2015 Jul 29.
- Nabhan F, Porter K, Lupo MA, Randolph GW, Patel KN, Kloos RT. Heterogeneity in Positive Predictive Value of RAS Mutations in Cytologically Indeterminate Thyroid Nodules. Thyroid. 2018 Jun;28(6):729-738. doi: 10.1089/thy.2017.0635. Epub 2018 May 16.
- Finoux AL, Chartrand P. [Oncogenic and tumour suppressor microRNAs]. Med Sci (Paris). 2008 Dec;24(12):1049-54. doi: 10.1051/medsci/200824121049. French.
- Boufraqech M, Klubo-Gwiezdzinska J, Kebebew E. MicroRNAs in the thyroid. Best Pract Res Clin Endocrinol Metab. 2016 Oct;30(5):603-619. doi: 10.1016/j.beem.2016.10.001. Epub 2016 Nov 1.
- Dom G, Frank S, Floor S, Kehagias P, Libert F, Hoang C, Andry G, Spinette A, Craciun L, de Saint Aubin N, Tresallet C, Tissier F, Savagner F, Majjaj S, Gutierrez-Roelens I, Marbaix E, Dumont JE, Maenhaut C. Thyroid follicular adenomas and carcinomas: molecular profiling provides evidence for a continuous evolution. Oncotarget. 2017 Dec 8;9(12):10343-10359. doi: 10.18632/oncotarget.23130. eCollection 2018 Feb 13.
- Titov SE, Demenkov PS, Ivanov MK, Malakhina ES, Poloz TL, Tsivlikova EV, Ganzha MS, Shevchenko SP, Gulyaeva LF, Kolesnikov NN. Selection and validation of miRNAs as normalizers for profiling expression of microRNAs isolated from thyroid fine needle aspiration smears. Oncol Rep. 2016 Nov;36(5):2501-2510. doi: 10.3892/or.2016.5113. Epub 2016 Sep 20.
- Lithwick-Yanai G, Dromi N, Shtabsky A, Morgenstern S, Strenov Y, Feinmesser M, Kravtsov V, Leon ME, Hajduch M, Ali SZ, VandenBussche CJ, Zhang X, Leider-Trejo L, Zubkov A, Vorobyov S, Kushnir M, Goren Y, Tabak S, Kadosh E, Benjamin H, Schnitzer-Perlman T, Marmor H, Motin M, Lebanony D, Kredo-Russo S, Mitchell H, Noller M, Smith A, Dattner O, Ashkenazi K, Sanden M, Berlin KA, Bar D, Meiri E. Multicentre validation of a microRNA-based assay for diagnosing indeterminate thyroid nodules utilising fine needle aspirate smears. J Clin Pathol. 2017 Jun;70(6):500-507. doi: 10.1136/jclinpath-2016-204089. Epub 2016 Oct 26.
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- PROCIM 2020-02 PRE
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
IPD 共有時間枠
Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
IPD 共有アクセス基準
The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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