Assessment of Repeat Fine Needle Aspiration (FNA) to Detect Thyroid Cancer (CYT2THYR)
Recruitment status was Not yet recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Thyroid nodules are common (prevalence of 12.7% in women), but are malignant in only 5% of cases. International experts agree that a preliminary cytological examination by fine needle aspiration (FNA) is required. The management of patients with cytological results consistent with malignant or suspicious for malignancy nodules is well codified and generally involves surgery. However, there is no consensus concerning 1) the utility of a second FNA during the monitoring of benign nodules. Certain studies have recommended a second FNA, whereas others have recommended ultrasound monitoring alone; 2) the contribution of ultrasound criteria to the decision as to whether to carry out a second FNA, particularly if the nodule increases in size; 3) the management of nodules classified as doubtful or suspect on needle biopsy, many of which prove to be benign (20 to 30% are malignant), raising questions about the utility of systematic thyroid surgery or the justification for a second FNA; 4) the management of patients with non significant (NS) findings on FNA, for whom immediate surgery, monitoring or a second FNA may be recommended and 5) the procedure to be followed for nodules present in patients with multinodular thyroid disease.
| Condition | Intervention |
|---|---|
|
Thyroid Cancer |
Procedure: Fine needle aspiration |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Utility of a Second Ultrasound-guided Fine Needle Aspiration for the Detection of Thyroid Cancer in the Management of Single Thyroid Nodules or Multinodular Goitre. |
- Status nodule [ Time Frame: Inclusion, 6, 12 and 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Fine needle aspiration
Patient with solid nodules more than 10 mm in diameter will be biopsied by ultrasound-guided fine-needle aspiration(FNA)after consultation with an endocrinologist or ENT specialist.
|
Procedure: Fine needle aspiration
Classical needle biopsy techniques will be used, with patients lying on their backs with their necks in hyperextension. An initial ultrasound scan will be used to determine the site or sites at which the needle should be inserted. Following extensive disinfection of the skin of the neck, the needle will be inserted under ultrasound guidance. The needle will be moved gently backwards and forwards and displaced radially in a clockwise direction to recover cellular material by capillarity. In general, several (two or three) passages of the needle are required for a given nodule. It is possible to carry out FNA on up to three nodules in a single session. For each passage, a new, sterile, single-use needle will be used. The insertion of each needle will be preceded by an ultrasound scan.
Other Name: Fine needle aspiration under ultrasonography
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient are more than 18 years old
- Patient with a unique or several thyroid solid nodules more than 10 mm wide
- Patient who accept to be followed over 18 months
- Study Informed patient, non opposed to his/her own data analyzes
Exclusion Criteria:
- Pregnant women
- Patient with previous data of thyroid cancer
- Patient with low TSH (inferior to local norm)
- Patient refusing thyroid surgery policy/ rule
- Irresponsible patient or patient refusing to participate
- Patient with clinical or psychological state not permitting study sample
Contacts and Locations| Contact: Marie LALOI-MICHELIN, MD | +33(0)149956380 | marie.laloi-michelin@lrb.aphp.fr |
| Contact: Béatrix COCHAND-PRIOLLET, MD-PHD | +33(0)149958330 | beatrix.cochand-priollet@lrb.aphp.fr |
| France | |
| Service de Médecine Interne B - Hôpital LARIBOISIERE | Not yet recruiting |
| Paris, Ile de France, France, 75010 | |
| Contact: Marie LALOI-MICHELIN, MD +33(0)149956380 marie.laloi-michelin@lrb.aphp.fr | |
| Contact: Béatrix COCHAND-PRIOLLET, MD +33(0)149958330 beatrix.cochand-priollet@lrb.aphp.fr | |
| Principal Investigator: Marie LALOI-MICHELIN, MD | |
| Principal Investigator: | Marie LALOI-MICHELIN, MD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Eric VICAUT, Unité de Recherche Clinique Lariboisière |
| ClinicalTrials.gov Identifier: | NCT00954837 History of Changes |
| Other Study ID Numbers: | ID RCB 2008-A00839-46 |
| Study First Received: | July 30, 2009 |
| Last Updated: | February 26, 2010 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Thyroid cancer thyroid FNA repeat FNA |
thyroid screening thyroid ultrasonography FNA screening |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Thyroid Diseases Endocrine Gland Neoplasms Neoplasms by Site |
Neoplasms Head and Neck Neoplasms Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013