NCT01586520

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

April 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

3.5 years

First QC Date

April 25, 2012

Last Update Submit

September 14, 2017

Conditions

Differentiated Thyroid Cancer

Keywords

thyroid cancer, papillary, follicular, proteomics, genetic markers

Outcome Measures

Primary Outcomes (1)

  • Proteomic markers of differentiated thyroid cancer

    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.

    24 months

Secondary Outcomes (1)

  • Genetic markers of diffferentiated thyroid cancer

    24 months

Study Arms (2)

Disease positive

Imaging or biopsy evidence of disease

Disease negative

No evidence of disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

400 patients attending the regional thyroid cancer clinic (Northern Centre for Cancer Care) over 24 months will be recruited.

You may qualify if:

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

You may not qualify if:

  • Age of less than 18 years.
  • Patient has additional risk infections (HIV, Hep B/C)
  • Patient is involved in other medicinal or treatment based clinical trial at the time of recruitment or in the previous 4 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sir Bobby Robson Cancer Researhc Unit

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

Location

Sir Bobby Robson Cancer Research Unit, Northern Centre for cancer care

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, DNA and RNA

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2012

First Posted

April 26, 2012

Study Start

April 1, 2011

Primary Completion

October 1, 2014

Study Completion

December 1, 2016

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations

GB(2)