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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01588288
First received: April 25, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Goiter, Nodular
Procedure: Galectin 3 dosage

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Diagnosis Interest of Galectin 3 Dosage in Nodular and Multinodular Goiter Pretreatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Sensitivity (Se) and specificity (Sp) of plasmatic galectin 3 dosage in preoperative [ Time Frame: 1 day ] [ Designated as safety issue: No ]

    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 [ Time Frame: Once in preoperative ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 500
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Galectin 3 dosage
Preoperative Galectin 3 dosage in plasma and water rinse of the needle aspiration biopsy
Procedure: Galectin 3 dosage
Preoperative Galectin 3 dosage in plasma and water rinse of the needle aspiration biopsy.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588288

Contacts
Contact: Olivier Choussy, Dr 33(0)2 32 88 36 31 olivier.choussy@chu-rouen.fr
Contact: Hind Berrahmoune 33(0)2 32 88 89 90 ext 63852 hind.berrahmoune@chu-rouen.fr

Locations
France
Centre Henri Becquerel Recruiting
Rouen, France, 76000
Contact: Frederic Decourselle, Dr       'frederic.decourselle@chb.unicancer.fr'   
Sub-Investigator: F Decourselle, Dr         
Sub-Investigator: P. Vera, Pr         
Sub-Investigator: J-P Basuyeau, Dr         
Sub-Investigator: F Callonnec, Dr         
Sub-Investigator: S Laberge, Dr         
CHRouen Recruiting
Rouen, France, 76000
Contact: Hind Berrahmoune    33(0)2 32 88 89 90 ext 63852    hind.berrahmoune@chu-rouen.fr   
Contact: Olivier Choussy, Dr    33(0)2 32 88 36 31    olivier.choussy@chu-rouen.fr   
Principal Investigator: O Choussy, Dr         
Sub-Investigator: D Dehesdin, Pr         
Sub-Investigator: J-M Kuhn, Pr         
Sub-Investigator: A-F Cailleux, Dr         
Sub-Investigator: F Roussel, Dr         
Sub-Investigator: E Touré, Dr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Olivier Choussy, Dr CHRouen, France
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01588288     History of Changes
Other Study ID Numbers: 2011/042/HP, 2011-A00569-32
Study First Received: April 25, 2012
Last Updated: January 6, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Diagnosis
Galectin 3
Puncture
Goiter, nodular
Surgery

Additional relevant MeSH terms:
Goiter
Goiter, Nodular
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 29, 2014