interNational Anaplastic Thyroid Cancer Tissue Bank and Database (iNATT)
iNATT
1 other identifier
observational
350
2 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2013
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2013
CompletedFirst Posted
Study publicly available on registry
January 23, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJanuary 5, 2021
December 1, 2020
11.7 years
January 18, 2013
December 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
up to 12months
Study Arms (1)
anaplastic thyroid cancer
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patients with non anaplastic thyroid cancer including medullary thyroid cancer, papillary thyroid cancer, follicular thyroid cancer, thyroid lymphoma
- Patients unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Beaumont Hospital
Dublin, Ireland
St Vincent's Hospital
Dublin, Ireland
Galway University Hospital
Galway, Ireland
Addenbrookes Hospital
Cambridge, United Kingdom
Velindre Hospital
Cardiff, CF14 2TL, United Kingdom
University Hospitals of Coventry and Warwickshire
Coventry, United Kingdom
Castle Hill Hospital
Hull, United Kingdom
St James' Institute
Leeds, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, United Kingdom
Nottingham University NHS Trust
Nottingham, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, United Kingdom
Weston Park Hospital
Sheffield, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Related Links
Biospecimen
Anaplastic thyroid cancer tissue blocks and slides. EDTA blood sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Moss, MB BCh
Velindre University NHS Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Clinical Oncologist
Study Record Dates
First Submitted
January 18, 2013
First Posted
January 23, 2013
Study Start
June 1, 2013
Primary Completion
February 1, 2025
Study Completion
March 1, 2025
Last Updated
January 5, 2021
Record last verified: 2020-12