Condition category
Cancer
Date applied
28/01/2015
Date assigned
28/01/2015
Last edited
14/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Mr Andrew Palmer

ORCID ID

Contact details

Birmingham Clinical Trials Unit (BCTU)
Institute of Applied Health Research
College of Medical and Dental Sciences
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 121 415 9965
a.palmer@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17373

Study information

Scientific title

The efficacy and cost effectiveness of real time ultrasound elastography in the investigation of thyroid nodules and the diagnosis of thyroid cancer

Acronym

ElaTION

Study hypothesis

The aim of this study is to compare the use of real time elastography (RTE) in conjunction with ultrasound to guide fine needle aspiration cytology FNAC (the intervention) with conventional ultrasound-only guided FNAC (current practice–comparator).

Ethics approval

NREC Committee South Central- Berkshire, 10/10/2014, ref: 14/SC/1206

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Topic: Cancer, Ear, nose and throat; Subtopic: Head and Neck Cancer, Ear (all Subtopics); Disease: Endocrine, Head and Neck

Intervention

Intervention arm- Real-time ultrasound elastography – guided FNAC. RTE is a technology that can be added at the same time as the routine ultrasound examination, and may help differentiate benign from malignant nodules based on the compression characteristics of the two.; Follow Up Length: 12 month(s)

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Primary outcome measure as of 14/02/2017:
The proportion of patients who have a non-diagnostic (Thy1) cytology result following the first FNAC.

Original primary outcome measure:
The rate of benign histology result following thyroid surgery, compared between the RTE-FNAC arm and the conventional US-FNAC arm.

Secondary outcome measures

Secondary outcome measures as of 14/02/2017:
1. Number of FNACs required to obtain definitive diagnosis
2. Time from first FNAC to obtaining a definitive diagnosis
3. The proportion of patients with benign histology results following thyroidectomy
4. Proportion of patients who have thyroidectomy
5. Accuracy of a cytology results for first FNAC and repeated FNAC in relation to overall definitive diagnosis;
6. Accuracy of an imaging assessment on ultrasound (with or without RTE) alone diagnostic protocol in relation to overall definitive diagnosis
7. Patient reported outcome measures of depression and anxiety, pain, and quality of life: the Hospital Anxiety and Depression rating scale (HADS), Visual Analogue Pain Score (VAPS) and EQ-5D quality of life score
8. Radiologist report of whether RTE had contributed to the radiologist’s decisions, how easy they found using RTE, and whether they found it helpful above using US-alone in predicting malignancy
9. Complication rate from any thyroidectomy at 30-days and 6-months post-surgery – to include haematoma and temporary hypocalcaemia rate at 30 days and vocal cord palsy and permanent hypocalcaemia at 6 months post-operative
10. Resource usage for consultant time and diagnostic testing procedures and subsequent management including consultations and surgical treatments

Original secondary outcome measures:
1. Overall number of FNAC's Required and time to obtain a definitive diagnosis in each arm
2. Non-diagnostic cytology (Thy1) rate for the first FNAC undertaken in each patient
3. Resource use for consultation time and diagnostic testing procedures and quality of life (EQ-5D)
4. Predictive value of a benign (Thy2) cytology results for first FNAC and repeated FNAC in relation to overall definitive diagnosis for RTE-FNAC and conventional US-FNAC
5. Patients reported anxiety immediately before and after US FNAC, immediately before each consultation for results of US FNA or surgery and at 6 and 12 months from initial US FNAC
6. Radiologist survey-completed by Radiologists at the end of the procedure to identify whether radiologists found US or RTE had contributed to their decision, ease of use, and their prediction of malignancy of the nodule using RTE or US features alone
7. Agreement rates for RTE between local operator and RTE or US features alone
8. Patient reported pain (by Visual analogue score) at procedure
9. Complication rate from any thyroidectomy- haematoma rate, vocal cord palsy at 6 months, permanent hypocalcaemia rate at 6 months
10. Cost-benefit analysis

Overall trial start date

20/11/2014

Overall trial end date

30/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with single or multiple thyroid nodules whether solid, cystic or mixed, undergoing investigation who have not undergone previous FNAC within the last 6 months
2. Aged 18 or over
3. Patient able and willing to give written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 968; UK Sample Size: 968

Participant exclusion criteria

1. Patients who have undergone previous thyroid FNAC in the last 6 months.
2. Patients with a bleeding diathesis that precludes FNAC
3. Patients with a needle phobia. 
4. Pregnant patients 
5. Patients with purely cystic nodules or with recent haemorrhage, with no solid component

Recruitment start date

27/02/2015

Recruitment end date

30/11/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials Unit (University of Birmingham)
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Institute for Cancer Studies
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/02/2017: The following changes have been made to the record: 1. The target number of participants has been updated from 1000 to 968 2. Within "the last 6 months" has been added to the first inclusion criteria and exclusion criteria 3. The outcome measures have been updated 30/11/2016: The study contact has been changed from Mrs Sarah Khan to Mr Andrew Palmer.