Goiter, Nodular Clinical Trial
— GalectinsOfficial title:
Diagnosis Interest of Galectin 3 Dosage in Nodular and Multinodular Goiter Pretreatment
The investigators will dose galectin 3 in plasma and water rinse of the needle aspiration biopsy in patients with thyroid nodules. The investigators aim to show that preoperative dosage of the galectin 3 could provide good diagnosis of malignant versus benign thyroid cancer.
Status | Completed |
Enrollment | 193 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Men and women - 18 years old or more - Patient with one or more thyroid nodules with the following definition : A nodule is a circumscribed intraparenchymal expansive development. This is thus a structure that appears on two cuts perpendicular ovoid. a nodule is visible on ultrasound by their mass effect (contour deformation), its ultrasound contrast relative to adjacent parenchyma or by repression of vascular structures at its periphery (halo and cantilever) - Indication for a cytopuncture, in the opinion of the investigator - Definitive postoperative histological analysis confirming a benign or malignant tumor of vesicular lineage cells. - Patient affiliated to the french public welfare system - Patient who signed an informed consent Exclusion Criteria: - Simple goiter - Thyroid dysfunction - Hashimoto's thyroiditis - Basedow's disease - No surgery at the end of the study - After definitive postoperative histological analysis : lymphoma, medullary thyroid carcinoma, anaplastic thyroid cancer, or focal Hashimoto's thyroiditis - Pregnancy - Major under guardianship, - Person deprived from him administrative and judicial liberty |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | Centre Henri Becquerel | Rouen | |
France | CHRouen | Rouen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity (Se) and specificity (Sp) of plasmatic galectin 3 dosage in preoperative | Se and Sp of plasmatic galectin 3 dosage will be established relative to the reference method which is the histological analysis of the specimen (report) asserting the existence of a vesicular lineage tumor, benign (adenoma) or malignant (papillary or follicular). The threshold giving the best compromise for the values of Se and Sp will be searched graphically. Then the area under the curve and its confidence interval at 95% will be calculated and will be tested against the value 0.5, that is to say an area where the assay has no diagnostic value. |
1 day | No |
Secondary | Sensitivity (Se) and specificity (Sp) of preoperative galectin 3 dosage in the water rinse of the needle aspiration biopsy | Se and Sp of galectin 3 dosage in the water rinse of the needle aspiration biopsy will be established relative to the reference method which is the histological analysis of the specimen (report) asserting the existence of a vesicular lineage tumor, benign (adenoma) or malignant (papillary or follicular). The threshold giving the best compromise for the values of Se and Sp will be searched graphically. Then the area under the curve and its confidence interval at 95% will be calculated and will be tested against the value 0.5, that is to say an area where the assay has no diagnostic value. |
Once in preoperative | No |
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