interNational Anaplastic Thyroid Cancer Tissue Bank and Database (iNATT) (iNATT)
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| ClinicalTrials.gov Identifier: NCT01774279 |
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Recruitment Status :
Recruiting
First Posted : January 23, 2013
Last Update Posted : May 22, 2018
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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 |
Show Detailed Description
| 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 2022 |
| Estimated Study Completion Date : | March 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
| anaplastic thyroid cancer |
Other: Tissue, blood and clinical data collection |
- Overall survival [ Time Frame: up to 12months ]
Biospecimen Retention: Samples With DNA
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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 |
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
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 ClinicalTrials.gov identifier (NCT number): NCT01774279
| 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 |
| 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 | |
Additional Information:
| 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 Key Record Dates |
| Last Update Posted: | May 22, 2018 |
| Last Verified: | May 2018 |
Additional relevant MeSH terms:
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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 |