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Diagnosing Thyroid Cancer Using a Blood Test

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01586520
First Posted: April 26, 2012
Last Update Posted: September 15, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust
  Purpose
Thyroid cancer is a relatively rare disease but its incidence is increasing in many countries.. Early and accurate diagnosis leading to earlier treatment and intervention is recognised as a major factor in determining a good outcomes. This study will investigate new ways of diagnosing thyroid cancer from blood samples using proteomic and genetic markers. The study will take samples from patients with differentiated thyroid cancer and measure relative quantities of 1000s of proteins within the blood. These measures will be explored to see if, when used in combination they can accurately diagnose thyroid cancer. If successful this technique could be extended to routine screening and could replace more invasive tests currently used. Participants will be required to supply a small sample of blood, answer questions on their medical history and also consent for their medical records to be examined. A lifestyle questionnaire will also be supplied to each participant. In the case where a diagnosis is predicted for a condition the participant was not aware of the medical team will discuss the best interests of the patient with their GP and if required refer them to a suitable specialist. The study will run for 24 months and will routinely process around 15 and 20 participants with a history of thyroid cancer per month. All patient details will be kept confidential and only non identifiable information will leave the clinic. The work will be published and if successful will be validated on another site, commercialised and made available for routine clinical use.

Condition
Differentiated Thyroid Cancer

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Diagnosing Thyroid Cancer Using a Blood Test

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • Proteomic markers of differentiated thyroid cancer [ Time Frame: 24 months ]
    The primary objective of the study is to derive molecular (proteomic) diagnostic signatures that that can distinguish patients with recurrent / residual thyroid cancer from those with no residual disease.


Secondary Outcome Measures:
  • Genetic markers of diffferentiated thyroid cancer [ Time Frame: 24 months ]
    The secondary objective is to identify genetic markers of thyroid cancer status (recurrent / residual disease versus no disease) from peripheral blood samples. Information from the proteomics component of the study are expected to identify multiple potential protein markers. Genes encoding these differentially expressed proteins will be sequenced and will guide our team as to which genetic markers in peripheral blood may be targeted in order to improve the diagnostic power of molecular testing.


Biospecimen Retention:   Samples With DNA
serum, DNA and RNA

Enrollment: 400
Study Start Date: April 2011
Study Completion Date: December 2016
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Disease positive
Imaging or biopsy evidence of disease
Disease negative
No evidence of disease

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
400 patients attending the regional thyroid cancer clinic (Northern Centre for Cancer Care) over 24 months will be recruited.
Criteria

Inclusion Criteria:

  1. Age over 18 years.
  2. Patient has thyroid cancer.
  3. Patient is judged as being capable of understanding the information sheet and of giving informed consent (Mental Capacity Act 2005).
  4. Responsible clinician is approached and is happy for the patient to be included in the study.

Exclusion Criteria:

  1. Age of less than 18 years.
  2. Patient has additional risk infections (HIV, Hep B/C)
  3. Patient is involved in other medicinal or treatment based clinical trial at the time of recruitment or in the previous 4 months.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01586520


Locations
United Kingdom
Sir Bobby Robson Cancer Researhc Unit
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Sir Bobby Robson Cancer Research Unit, Northern Centre for cancer care
Newcastle upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
  More Information

Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01586520     History of Changes
Other Study ID Numbers: 5559
First Submitted: April 25, 2012
First Posted: April 26, 2012
Last Update Posted: September 15, 2017
Last Verified: September 2017

Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
thyroid cancer, papillary, follicular, proteomics, genetic markers

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