Thyroid NodeSWEETMACNCT01880203
Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study
A study testing aspiration in thyroid node for Molecular Cytogenetic Analysis. in people with Thyroid Node and Indeterminate Cytology, run by Centre Francois Baclesse at 4 sites in France.
Trial summary
The purpose of the study is to investigate the contribution of molecular cytological analysis (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with indeterminate cytology (IC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Node, Indeterminate Cytology, Surgery Indication
- What is being tested?
- aspiration in thyroid node for Molecular Cytogenetic Analysis.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesFrance
- Study dates
- May 2013to Nov 2015
- 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
- Age ≥ 18 years
- Patients with thyroid nodules ≥ 15 mm with an indeterminate cytology (IC) older than 6 months, for which a surgical indication was raised
- vesicular lesion of undetermined significance
- follicular neoplasm or Hurthle cells
- lesion suspicious for malignancy
- Confirmation of indeterminate cytology (IC) replay centralized
- Patient affiliated to a social security scheme
- Informed consent and signed
Who cannot join
- Thyroid node <15 mm
- Nodules coalescing preventing proper individualization of targeted nodule
- Indeterminate cytology older than six months
- Nodules with indeterminate cytology not, ie non-diagnostic cytology, benign and malignant cytology cytology
- Major subject to a measure of legal protection or unable to consent
- Refusal to participate
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre François BACLESSE
Caen, Calvados, 14000
CHU
Caen, Calvados, 14000
Hôpital Américain de Paris
Neuilly-sur-Seine
Hôpital Pitié-salpétrière
Paris, 75 000
About this study
The purpose of the study is to investigate the contribution of molecular cytological analysis (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with indeterminate cytology (IC)
- Conditions
- Thyroid Node, Indeterminate Cytology, Surgery Indication
- Being tested
- aspiration in thyroid node for Molecular Cytogenetic Analysis.
- Keywords
- thyroid, elastography SWE, indeterminate cytology
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspiration in thyroid node for Molecular Cytogenetic Analysis.Procedure or surgery
Also called cervical ultrasound with elastography SWE followed by a new ultrasound-guided fine needle aspiration for Molecular Cytogenetic Analysis.
| Study group | Role | What they receive |
|---|---|---|
| aspiration for Molecular Cytogenetic Analysis. | Experimental | Not described Receives: Procedure: aspiration in thyroid node for Molecular Cytogenetic Analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the diagnostic performance of the AMC and SWE elastography
Evaluate the diagnostic performance of the AMC and SWE elastography in patients with a thyroid nodule CI taking as reference the histology of the nodule.
Measured: at inclusion, before surgery
Secondary outcomes (2)
evaluate the diagnostic performance of elastography SWE
For elastography SWE validate decision thresholds for the parameters of elasticity of thyroid nodules, and evaluate the diagnostic performance of elastography SWE combined with those of the standard ultrasound.
Measured: at inclusion, before surgery
Establish a combined diagnostic score results of elastography
Establish a combined diagnostic score results of elastography, the standard ultrasound and molecular analysis
Measured: at inclusion, before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid NodeStudies of the same condition, open and under way.
- 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation avenir, laboratoire Genzyme
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880203
- Sponsor's protocol ID
- SWEETMAC
- Acronym
- SWEETMAC
- Status last verified
- Oct 2016
- First submitted
- 14 Jun 2013
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bardet S, Goardon N, Lequesne J, Vaur D, Ciappuccini R, Leconte A, Monpeyssen H, Saguet-Rysanek V, Clarisse B, Lasne-Cardon A, Menegaux F, Leenhardt L, Buffet C. Diagnostic and prognostic value of a 7-panel mutation testing in thyroid nodules with indeterminate cytology: the SWEETMAC study. Endocrine. 2021 Feb;71(2):407-417. doi: 10.1007/s12020-020-02411-4. Epub 2020 Jul 7.
PubMed 32638211
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study
- ClinicalTrials.gov ID
- NCT01880203
- Acronym / sponsor ID
- SWEETMAC / SWEETMAC
- Conditions
- Thyroid Node, Indeterminate Cytology, Surgery Indication
- Keywords
- thyroid, elastography SWE, indeterminate cytology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Fondation avenir, laboratoire Genzyme
- Study start
- May 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Jun 2013 (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 purpose of the study is to investigate the contribution of molecular cytological analysis (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with indeterminate cytology (IC)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aspiration for Molecular Cytogenetic Analysis. | Experimental | Procedure: aspiration in thyroid node for Molecular Cytogenetic Analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Patients with thyroid nodules ≥ 15 mm with an indeterminate cytology (IC) older than 6 months, for which a surgical indication was raised
- Confirmation of indeterminate cytology (IC) replay centralized
- Patient affiliated to a social security scheme
- Informed consent and signed
Key exclusion criteria (6 listed)
- Thyroid node <15 mm
- Nodules coalescing preventing proper individualization of targeted nodule
- Indeterminate cytology older than six months
- Nodules with indeterminate cytology not, ie non-diagnostic cytology, benign and malignant cytology cytology
- Major subject to a measure of legal protection or unable to consent
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 |
|---|---|---|
| aspiration in thyroid node for Molecular Cytogenetic Analysis.Also: cervical ultrasound with elastography SWE followed by a new ultrasound-guided fine needle aspiration for Molecular Cytogenetic Analysis. | Procedure or surgery | aspiration for Molecular Cytogenetic Analysis. |
Primary outcome
Evaluate the diagnostic performance of the AMC and SWE elastography
Time frame: at inclusion, before surgery
Evaluate the diagnostic performance of the AMC and SWE elastography in patients with a thyroid nodule CI taking as reference the histology of the nodule.
2 secondary outcomes
evaluate the diagnostic performance of elastography SWE
Time frame: at inclusion, before surgery
Establish a combined diagnostic score results of elastography
Time frame: at inclusion, before surgery
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 21 Oct 2016.
- Derived from this study: PubMed 32638211Bardet S, Goardon N, Lequesne J, Vaur D, Ciappuccini R, Leconte A, Monpeyssen H, Saguet-Rysanek V, Clarisse B, Lasne-Cardon A, Menegaux F, Leenhardt L, Buffet C. Diagnostic and prognostic value of a 7-panel mutation testing in thyroid nodules with indeterminate cytology: the SWEETMAC study. Endocrine. 2021 Feb;71(2):407-417. doi: 10.1007/s12020-020-02411-4. Epub 2020 Jul 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aspiration in thyroid node for Molecular Cytogenetic Analysis. in people with Thyroid Node and Indeterminate Cytology, run by Centre Francois Baclesse at 4 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 6 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 21 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 4 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?
Evaluate the diagnostic performance of the AMC and SWE elastography (time frame: at inclusion, before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01880203, which also lists 1 linked publication.
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 21 Oct 2016.