Predictive Value of microRNA in Thyroid Cytologies of Undetermined Type

Not Applicable

Recruiting

• Conditions: Thyroid Cancer
• Interventions: Diagnostic Test: Signature of microRNA for patients with bethesda classification 3, 4 or 5

• Registration Number: NCT04285476
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Study Start: 2021-06-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2026-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Signature of microRNA	Signature of microRNA for patients with bethesda classification 3, 4 or 5	Signature of miRNA in patients with Thyroid Cytologies of undetermined type and with a Bethesda classification 3, 4 or 5

Primary Outcome Measures

Name	Time	Method
Area under receiver operating characteristic (ROC) curve of the microRNA signature	24 months

Secondary Outcome Measures

Name	Time	Method
Sensitivity of the test (microRNA)	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.
Specificity of the test (microRNA)	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.
Positive predictive value (PPV) of the test (microRNA)	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).
Negative predictive value (NPV) of the test (microRNA)	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).

Trial Locations

Locations (3)

CHU de Nîmes; 🇫🇷 Nîmes, France

CHU de Toulouse; 🇫🇷 Toulouse, Haute-Garonne, France

Institut régional du Cancer de Montpellier; 🇫🇷 Montpellier, Hérault, France