Diagnosis Interest of Galectin 3 Dosage in Nodular and Multinodular Goiter Pretreatment
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
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 :
- 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).
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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.
Olivier Choussy, Dr
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)