Goiter, Nodular Clinical Trial
Official 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.
Endogenous cell-surface galectins have recently gained interest as antigenic determinants of
varied tumor tissue. They are also used as potential targets for antitumor therapy by
coupling cytotoxic molecules or radioisotopes either with carbohydrate residues, or with
antibodies antigalectines.
In addition, the plasma level dosage of galectin 3 seems possible and provides a diagnostic
help in thyroid lesions and in monitoring squamous cell head and neck.
In a study on thyroid tumors, the sensitivity [Se] and specificity [Sp] of the plasma level
was poor (just over 70%), but this study was conducted with a low and heterogeneous
recruitment (70 patients). The inclusion of a greater number of patients with a better
selection would better inform us about qualities of these diagnostic assays.
An additional argument would be the dosage of galectins in the water rinse of the needle
aspiration biopsy. This study has never been made so far and there is no evidence to predict
its sensitivity and specificity. The advantage is that galectin will not be "diluted" as
would be the case in an assay done in the blood. Moreover, it would select candidates for
dosage nodules, ie those whose size would impose, if it was a cancer, to resort to surgical
treatment more extensive than originally planned. Indeed, compared to preoperative already
existing metering "interesting" dosage would diagnose:
- with a good reliability (Se and Sp > 80%)
- a cancer requiring additional treatment (i.e. surgical revision to achieve a total
thyroidectomy, accompanied by lymph node dissection) resulting in a higher risk of
morbidity if reoperation.
The investigators therefore believe that preoperative galectin 3 dosage in plasma or in the
puncture water rinse could have strong arguments pointing to a neoplastic to a full initial
gesture in a single surgical step, a gesture much less risky and expensive.
In this study, patients benefit from routine monitoring of thyroid nodules according to
current recommendations. For surgical patients only, the information about the intervention
will be collected to know the final histological diagnosis.
Galectin 3 will be measured preoperatively in :
- plasma
- water rinse of FNA.
The diagnostic characteristics of the assays, sensitivity and specificity 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).
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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