Assessment of Repeat Fine Needle Aspiration (FNA) to Detect Thyroid Cancer (CYT2THYR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00954837
Recruitment Status : Withdrawn (administrative delays too long)
First Posted : August 7, 2009
Last Update Posted : May 27, 2013
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Thyroid Cancer Procedure: Fine needle aspiration Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : April 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Status nodule [ Time Frame: Inclusion, 6, 12 and 18 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00954837

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Marie LALOI-MICHELIN, MD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00954837     History of Changes
Other Study ID Numbers: ID RCB 2008-A00839-46
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013

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 Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms