Predictive Value of microRNA in Thyroid Cytologies of Undetermined Type (PREDICYTHY)

September 18, 2025 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

Study of the Predictive Value of a Signature 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU de Nîmes
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31000
        • CHU de Toulouse
    • Hérault
      • Montpellier, Hérault, France, 34298
        • Institut Regional Du Cancer de Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Signature of microRNA
Signature of miRNA in patients with Thyroid Cytologies of undetermined type and with a Bethesda classification 3, 4 or 5
Diagnostic test: Signature of microRNA for patients with bethesda classification 3, 4 or 5
If the cytology results are Bethesda 3, 4 or 5, then a miRNA analysis will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under receiver operating characteristic (ROC) curve of the microRNA signature
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
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.
24 months
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).
24 months
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).
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Thierry GALVEZ, MD, Institut Regional Du Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2021

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROCIM 2020-02 PRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients All participant data collected during the trial, after encoding with an inclusion number, 1st letter of the name and surname may be shared.

The data of the participants will be available upon request and with the completion of a contract between the promoter and the applicant.

The study protocol, the statistical analysis plan (PAS) and the analytical code may also be subject to data sharing as part of a transfer contract (RGPD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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