Using microRNA to improve thyroid cancer diagnosis
Study of the Predictive Value of a Signature of microRNA in Thyroid Cytologies of Undetermined Type
This study is trying to see if a new test using microRNA can help doctors better tell if thyroid nodules are cancerous in patients with uncertain test results, which could help avoid unnecessary surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Toulouse, Haute-Garonne and 2 other locations) |
| Trial ID | NCT04285476 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a microRNA signature to better stratify thyroid cytologies classified as indeterminate types (Bethesda 3, 4, and 5). The research will standardize pre-analytical stages and establish a positivity threshold, comparing microRNA results with ultrasound and histological data from surgical specimens. By focusing on a cohort of 70 patients, the study seeks to enhance the predictive accuracy for malignancy in thyroid nodules, potentially reducing unnecessary surgeries.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with Bethesda 3, 4, or 5 thyroid nodules requiring ultrasound and fine-needle aspiration cytology.
Not a fit: Patients with metastatic cancer unrelated to thyroid cancer or those who have recently stopped cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of thyroid cancer, reducing unnecessary surgeries for patients with benign nodules.
How similar studies have performed: While various biomarkers have been proposed for risk stratification in thyroid nodules, this study aims to validate a novel microRNA approach that has not been extensively tested in independent cohorts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toulouse, Haute-Garonne and 2 other locations
- CHU de Toulouse — Toulouse, Haute-Garonne, France (Recruiting)
- Institut régional du Cancer de Montpellier — Montpellier, Hérault, France (Recruiting)
- CHU de Nîmes — Nîmes, France (Recruiting)
Study contacts
- Study coordinator: Moussion Aurore
- Email: aurore.moussion@icm.unicancer.fr
- Phone: 0467612446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.