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Diagnosis Interest of Galectin 3 Dosage in Nodular and Multinodular Goiter Pretreatment


N/A
18 Years
N/A
Not Enrolling
Both
Goiter, Nodular

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Trial Information

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
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).


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity (Se) and specificity (Sp) of plasmatic galectin 3 dosage in preoperative

Outcome Description:

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.

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Olivier Choussy, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHRouen, France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2011/042/HP

NCT ID:

NCT01588288

Start Date:

June 2012

Completion Date:

December 2014

Related Keywords:

  • Goiter, Nodular
  • Diagnosis
  • Galectin 3
  • Puncture
  • Goiter, nodular
  • Surgery
  • Goiter
  • Goiter, Nodular

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