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Active, Not Recruiting

NCT Number: NCT04285476

Predictive Value of microRNA in Thyroid Cytologies of Undetermined Type

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Toulouse, Toulouse, Haute-Garonne, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Signature of microRNA for patients with bethesda classification 3, 4 or 5

Diagnostic Test

If the cytology results are Bethesda 3, 4 or 5, then a miRNA analysis will be performed.

Primary outcomes

  1. Area under receiver operating characteristic (ROC) curve of the microRNA signature

    Time frame: 24 months

Secondary outcomes

  1. Sensitivity of the test (microRNA)

    Time frame: 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.

  2. Specificity of the test (microRNA)

    Time frame: 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.

  3. Positive predictive value (PPV) of the test (microRNA)

    Time frame: 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).

  4. Negative predictive value (NPV) of the test (microRNA)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

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

Acronym: PREDICYTHY

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2020
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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