Clinical trial NCT04285476: Predictive Value of microRNA in Thyroid Cytologies of Undetermined Type
Official title: Study of the Predictive Value of a Signature of microRNA in Thyroid Cytologies of Undetermined Type
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Area under receiver operating characteristic (ROC) curve of the microRNA signature
timeFrame: 24 months
Secondary outcomes:
measure: Sensitivity of the test (microRNA)
timeFrame: 24 months
measure: Specificity of the test (microRNA)
timeFrame: 24 months
measure: Positive predictive value (PPV) of the test (microRNA)
timeFrame: 24 months
measure: Negative predictive value (NPV) of the test (microRNA)
timeFrame: 24 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
state: Haute-Garonne
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier
state: Hérault
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Institut régional du Cancer de Montpellier
name: Riviere Christine, MD
role: STUDY_CHAIR
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