Goiter, NodularGalectinsNCT01588288
Galectin 3 Dosage in Diagnosis of Nodular and Multinodular Goiter
A study testing Galectin 3 dosage in people with Goiter, Nodular, run by University Hospital, Rouen at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Goiter, Nodular
- What is being tested?
- Galectin 3 dosage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Major under guardianship,
- Person deprived from him administrative and judicial liberty
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Diagnosis Interest of Galectin 3 Dosage in Nodular and Multinodular Goiter Pretreatment
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.
Read the 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).
- Conditions
- Goiter, Nodular
- Being tested
- Galectin 3 dosage
- Keywords
- Diagnosis, Galectin 3, Puncture, Goiter, nodular, Surgery
- Medical subject headings
- Goiter, Nodular, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galectin 3 dosageProcedure or surgery
Preoperative Galectin 3 dosage in plasma and water rinse of the needle aspiration biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Galectin 3 dosage | Experimental | Preoperative Galectin 3 dosage in plasma and water rinse of the needle aspiration biopsy Receives: Procedure: Galectin 3 dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
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.
Measured: Once in preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Goiter, NodularStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne CAILLEUX, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588288
- Sponsor's protocol ID
- 2011/042/HP
- Other IDs
- 2011-A00569-32
- Acronym
- Galectins
- Status last verified
- Oct 2016
- First submitted
- 25 Apr 2012
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis Interest of Galectin 3 Dosage in Nodular and Multinodular Goiter Pretreatment
- ClinicalTrials.gov ID
- NCT01588288
- Acronym / sponsor ID
- Galectins / 2011/042/HP
- Conditions
- Goiter, Nodular
- Keywords
- Diagnosis, Galectin 3, Puncture, Goiter, nodular, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Galectin 3 dosage | Experimental | Procedure: Galectin 3 dosagePreoperative Galectin 3 dosage in plasma and water rinse of the needle aspiration biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- Simple goiter
- Thyroid dysfunction
- Hashimoto's thyroiditis
- Basedow's disease
- No surgery at the end of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galectin 3 dosagePreoperative Galectin 3 dosage in plasma and water rinse of the needle aspiration biopsy. | Procedure or surgery | Galectin 3 dosage |
Primary outcome
Sensitivity (Se) and specificity (Sp) of plasmatic galectin 3 dosage in preoperative
Time frame: 1 day
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 secondary outcome
Sensitivity (Se) and specificity (Sp) of preoperative galectin 3 dosage in the water rinse of the needle aspiration biopsy
Time frame: Once in preoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne CAILLEUX, MD principal investigator
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galectin 3 dosage in people with Goiter, Nodular, run by University Hospital, Rouen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (Se) and specificity (Sp) of plasmatic galectin 3 dosage in preoperative (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2016.