National Anaplastic Thyroid Cancer Tissue Bank and Database (NATT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Velindre NHS Trust
Sponsor:
Information provided by (Responsible Party):
Dr Laura Moss, Velindre NHS Trust
ClinicalTrials.gov Identifier:
NCT01774279
First received: January 18, 2013
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

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 Intervention
Anaplastic Thyroid Cancer
Other: Tissue, blood and clinical data collection

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: National Anaplastic Thyroid Cancer Tissue Bank and Database (NATT). A UK Research Tissue Bank

Resource links provided by NLM:


Further study details as provided by Velindre NHS Trust:

Primary Outcome Measures:
  • Overall survival [ Time Frame: up to 12months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Anaplastic thyroid cancer tissue blocks and slides. EDTA blood sample


Estimated Enrollment: 350
Study Start Date: February 2013
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
anaplastic thyroid cancer Other: Tissue, blood and clinical data collection

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All UK anaplastic thyroid cancer patients. It is unknown with the currently available UK data on thyroid cancer incidence precisely how many cases of anaplastic thyroid arise annually. It is estimated that 70-90 new cases are diagnosed per year.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774279

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
United Kingdom
Velindre Hospital Not yet 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         
Sponsors and Collaborators
Velindre NHS Trust
  More Information

Additional Information:
No publications provided

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
Study First Received: January 18, 2013
Last Updated: January 22, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014