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Galectin 3 Dosage in Diagnosis of Nodular and Multinodular Goiter (Galectins)

Primary Purpose

Goiter, Nodular

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Galectin 3 dosage
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Goiter, Nodular focused on measuring Diagnosis, Galectin 3, Puncture, Goiter, nodular, Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Henri Becquerel
  • CHRouen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Galectin 3 dosage

Arm Description

Preoperative Galectin 3 dosage in plasma and water rinse of the needle aspiration biopsy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 25, 2012
Last Updated
October 7, 2016
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT01588288
Brief Title
Galectin 3 Dosage in Diagnosis of Nodular and Multinodular Goiter
Acronym
Galectins
Official Title
Diagnosis Interest of Galectin 3 Dosage in Nodular and Multinodular Goiter Pretreatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Goiter, Nodular
Keywords
Diagnosis, Galectin 3, Puncture, Goiter, nodular, Surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Galectin 3 dosage
Arm Type
Experimental
Arm Description
Preoperative Galectin 3 dosage in plasma and water rinse of the needle aspiration biopsy
Intervention Type
Procedure
Intervention Name(s)
Galectin 3 dosage
Intervention Description
Preoperative Galectin 3 dosage in plasma and water rinse of the needle aspiration biopsy.
Primary Outcome Measure Information:
Title
Sensitivity (Se) and specificity (Sp) of plasmatic galectin 3 dosage in preoperative
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Sensitivity (Se) and specificity (Sp) of preoperative galectin 3 dosage in the water rinse of the needle aspiration biopsy
Description
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.
Time Frame
Once in preoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne CAILLEUX, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
CHRouen
City
Rouen
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

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Galectin 3 Dosage in Diagnosis of Nodular and Multinodular Goiter

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