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Trial record 1 of 1 for:    NCT01774279
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interNational Anaplastic Thyroid Cancer Tissue Bank and Database (iNATT) (iNATT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01774279
Recruitment Status : Recruiting
First Posted : January 23, 2013
Last Update Posted : January 5, 2021
Information provided by (Responsible Party):
Dr Laura Moss, Velindre NHS Trust

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 15 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 interNational Anaplastic Thyroid Cancer Tissue Bank and Database Project (iNATT) 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 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 (iNATT).
Study Start Date : June 2013
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
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.


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

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): NCT01774279

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Contact: Laura J Moss, MB BCh +44 2920316205
Contact: Alison Parry-Jones, PhD +44 29 20743243

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Beaumont Hospital Recruiting
Dublin, Ireland
St Vincent's Hospital Recruiting
Dublin, Ireland
Galway University Hospital Recruiting
Galway, 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   
Principal Investigator: Laura J Moss, MB BCh         
University Hospitals of Coventry and Warwickshire Recruiting
Coventry, United Kingdom
Castle Hill Hospital Recruiting
Hull, United Kingdom
Contact: James England, MD         
St James' Institute Recruiting
Leeds, United Kingdom
Royal Marsden Hospital Recruiting
London, United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust Active, not recruiting
Norwich, United Kingdom
Nottingham University NHS Trust Recruiting
Nottingham, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust Recruiting
Romford, United Kingdom
Weston Park Hospital Recruiting
Sheffield, United Kingdom
Contact: Jon Wadsley, MD         
Royal Shrewsbury Hospital Recruiting
Shrewsbury, United Kingdom
New Cross Hospital Recruiting
Wolverhampton, United Kingdom
Sponsors and Collaborators
Velindre NHS Trust
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Principal Investigator: Laura Moss, MB BCh Velindre University NHS Trust
Additional Information:
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Responsible Party: Dr Laura Moss, Consultant Clinical Oncologist, Velindre NHS Trust Identifier: NCT01774279    
Other Study ID Numbers: 12/WA/0336
12/WA/0336 ( Other Identifier: Research Ethics Committee for Wales )
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Carcinoma, Anaplastic
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type