Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
FNAC in thyroid lumps
Study hypothesis
Does obtaining samples by non-suction technique give similar or better results than the suction method?
Ethics approval
Local Research Ethics Committee, 27/10/2005
Study design
A single blind randomised controlled study: study allocation numbers will be concealed in opaque enevelopes and slides will be blinded to the pathologist
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Multiple or single thyroid nodules
Intervention
Diseased thyoid tissue will be aspirated for cytological study using a fine bore needle
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Good quality slides for laboratory examination
2. To find the test that gives the highest yield of accurate results
Secondary outcome measures
1. All slides will be scored based on the amount of bloodstaining, cellularity and preservation of the cells
2. Patient satisfaction would be surveyed using a questionnaire
Overall trial start date
07/02/2006
Overall trial end date
31/07/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients referred to the Thyroid Lump Clinic, City Hospital, Birmingham
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
280 patients
Participant exclusion criteria
1. Children under 16 years of age
2. Patients unable to give consent for the study
3. Adults in emergency situations
Recruitment start date
07/02/2006
Recruitment end date
31/07/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Otolaryngology
Birmingham
B18 7QH
United Kingdom
Sponsor information
Organisation
Sandwell and West Birmingham Hospitals NHS Trust (UK)
Sponsor details
Research and Development
Arden House
City Hospital
Birmingham
B18 7QH
United Kingdom
+ 44 (0)121 5074091
lisa.proctor@swbh.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Sandwell and West Birmingham Hospitals NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list