NCT01588288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

April 25, 2012

Last Update Submit

October 7, 2016

Conditions

Goiter, Nodular

Keywords

DiagnosisGalectin 3PunctureGoiter, nodularSurgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (1)

  • Sensitivity (Se) and specificity (Sp) of preoperative galectin 3 dosage in the water rinse of the needle aspiration biopsy

    Once in preoperative

Study Arms (1)

Galectin 3 dosage

EXPERIMENTAL

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

Procedure: Galectin 3 dosage

Interventions

Galectin 3 dosagePROCEDURE

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

Galectin 3 dosage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Henri Becquerel

Rouen, 76000, France

Location

CHRouen

Rouen, 76000, France

Location

MeSH Terms

Conditions

Goiter, NodularDisease

Condition Hierarchy (Ancestors)

GoiterThyroid DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anne CAILLEUX, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2012

First Posted

April 30, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 10, 2016

Record last verified: 2016-10

Locations

FR(2)