interNational Anaplastic Thyroid Cancer Tissue Bank and Database (iNATT) (iNATT)

Study Description

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Brief Summary:

Anaplastic thyroid cancer has historically proven very difficult to research due to a combination of its rarity and the associated short survival period for those affected. In 2009, 2340 patients in the UK were diagnosed with thyroid cancer with 70-90 expected to be the anaplastic subtype 1,2. For these patients average life expectancy is in the range of 2-6 months with only a very small number surviving for more than one year. It is a highly aggressive form of cancer that is refractory to current treatment options. By collecting tissue and blood samples along with clinical data across the UK we will be able to accumulate numerically significant numbers of samples and data points which will facilitate research opportunities. Researchers will be encouraged to apply for access to the collected samples in order to try and establish the causal mechanisms for disease development, potential therapeutic targets and to relate clinical course and outcome with specific molecular defects. Due to the rarity it is not feasible for a single cancer centre or cancer network to accumulate sufficient samples for research in a meaningful timeframe hence the need for national collaboration in order to try and offer patients with this disease hope in the future.

All UK patients with anaplastic thyroid cancer would be potentially eligible. The project is expected to run for at least 5 years and all thyroid cancer clinicians will be encouraged to participate. Patients will be asked to donate surplus thyroid cancer tissue following routine biopsy procedures along with an optional blood sample.

2. Objectives

Primary Objectives The primary objective of this project is to establish a national anaplastic thyroid cancer tissue collection to help facilitate both basic and translational research opportunities.

There is no direct research question that the project itself addresses at this stage. The research proposals that subsequently arise as a result of this project will be generated by accredited research parties from the UK and potentially internationally. These research proposals will be submitted to the National Anaplastic Thyroid Cancer Tissue Bank and Database Project (NATT) Steering Committee for assessment. As the volume of material collected per patient is expected to be of small volume, by virtue of the specimen comprising core biopsy or fine needle aspirate material, research proposals will need to be prioritised according to the potential benefits the proposed research offers. Priority will be given to projects that may lead to the identification of potential therapeutic targets. Each research proposal will require their own ethical approval and research and development assessments before commencing.

The steering committee will be multidisciplinary and will include nationally respected researchers and thyroid cancer clinicians.

Scientific Justification The long term objective is to try and address the current lack of understanding about the aetiology and progression of this disease and ultimately to develop new therapeutic interventions that may slow the rate of disease progression, improve quality of life and prolong what is currently a very short survival.

Due to the short prognosis following diagnosis it is notoriously difficult to run interventional therapeutic clinical trials in this patient population. Patients usually present with locally advanced and metastatic disease and as a consequence are often of poor performance status making clinical trial participation very problematic. If potential therapeutic targets could be identified in vivo it would potentially open up new therapeutic avenues whilst sparing some patients with the 'wrong' molecular profile futile treatment.

This is a unique project within the setting of anaplastic thyroid cancer research.

Condition or disease	Intervention/treatment
Anaplastic Thyroid Cancer	Other: Tissue, blood and clinical data collection

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Study Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	350 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Target Follow-Up Duration:	12 Months
Official Title:	interNational Anaplastic Thyroid Cancer Tissue Bank and Database (NATT).
Study Start Date :	June 2013
Estimated Primary Completion Date :	February 2018
Estimated Study Completion Date :	February 2019

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
anaplastic thyroid cancer	Other: Tissue, blood and clinical data collection

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Overall survival [ Time Frame: up to 12months ]

Biospecimen Retention:   Samples With DNA

Anaplastic thyroid cancer tissue blocks and slides. EDTA blood sample

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 100 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Since August 2014 ethical approval has been granted to open this UK initiated study internationally. The project has therefore been rebranded the interNational Anaplastic Thyroid Cancer Tissue Bank (iNATT) project.

It is unknown with the currently available UK data on thyroid cancer incidence precisely how many cases of anaplastic thyroid arise annually in the UK. If the annual incidence is 2-4% it is estimated that 50-100 new cases are diagnosed per year in the UK.

Criteria

Inclusion Criteria:

• All patients with anaplastic thyroid cancer who are able to provide informed consent.
• Patients with foci of anaplastic thyroid cancer within a more differentiated thyroid cancer who are able to provide informed consent

Exclusion Criteria:

• Patients with non anaplastic thyroid cancer including medullary thyroid cancer, papillary thyroid cancer, follicular thyroid cancer, thyroid lymphoma
• Patients unable to provide informed consent

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Laura J Moss, MB BCh	+44 2920316205	laura.moss@wales.nhs.uk
Contact: Alison Parry-Jones, PhD	+44 29 20743243	Parry-JonesA@cardiff.ac.uk

Locations

Ireland
Beaumont Hospital	Active, not recruiting
Dublin, Ireland
St Vincent's Hospital	Active, not recruiting
Dublin, Ireland
United Kingdom
Addenbrookes Hospital	Recruiting
Cambridge, United Kingdom
Contact: Sarah Jefferies, MD
Velindre Hospital	Recruiting
Cardiff, United Kingdom, CF14 2TL
Contact: Laura J Moss, MB BCh +44 2920316205 laura.moss@wales.nhs.uk
Principal Investigator: Laura J Moss, MB BCh
University Hospitals of Coventry and Warwickshire	Active, not recruiting
Coventry, United Kingdom
Castle Hill Hospital	Recruiting
Hull, United Kingdom
Contact: James England, MD
St James' Institute	Active, not recruiting
Leeds, United Kingdom
Royal Marsden Hospital	Active, not recruiting
London, United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust	Active, not recruiting
Norwich, United Kingdom
Weston Park Hospital	Recruiting
Sheffield, United Kingdom
Contact: Jon Wadsley, MD
Royal Shrewsbury Hospital	Recruiting
Shrewsbury, United Kingdom
New Cross Hospital	Active, not recruiting
Wolverhampton, United Kingdom

Sponsors and Collaborators

Velindre NHS Trust

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Wales Cancer Bank 

Responsible Party:	Dr Laura Moss, Consultant Clinical Oncologist, Velindre NHS Trust
ClinicalTrials.gov Identifier:	NCT01774279 History of Changes
Other Study ID Numbers:	12/WA/0336; 12/WA/0336 ( Other Identifier: Research Ethics Committee for Wales )
First Posted:	January 23, 2013
Last Update Posted:	November 8, 2016
Last Verified:	November 2016

Additional relevant MeSH terms:

Thyroid Diseases; Thyroid Neoplasms; Thyroid Carcinoma, Anaplastic; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site	Neoplasms; Head and Neck Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type