NCT04133870

Brief Summary

This is a two part study; part A proposes to collect plasma samples to examine how ctDNA (circulating thyroid DNA) markers correlate with detection of recurrent disease, response to therapy, clinical outcome and pathological data. Part B aims to use tissue obtained from biopsies of primary or recurrent disease to establish cell lines and tumour explants to further investigate the biology of thyroid cancer in the preclinical setting

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 21, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

October 21, 2019

Status Verified

November 1, 2018

Enrollment Period

2.4 years

First QC Date

January 26, 2017

Last Update Submit

October 17, 2019

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (2)

  • Primary Objective

    Part A: blood and tumour tissue will be measured to determine molecular profiling.

    3 Years (at the end of study)

  • Primary Objective

    Part B: blood and tumour tissue will be assessed to establish cell lines and to determine patient derived xenograft (PDX) models of thyroid cancer

    3 years (at end of study)

Eligibility Criteria

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

This is a biological study to obtain tissue and blood samples from patients with advanced thyroid cancer

You may qualify if:

  • T3-4, N0-1b, M0-M1 thyroid cancer (papillary, follicular, poorly differentiated, anaplastic and medullary thyroid carcinoma).
  • Patient able to provide informed consent
  • Patient attending the Royal Marsden Hospital for inpatient or outpatient review
  • Sufficient tissue sample available to perform analysis (archived or fresh)
  • Adults \>16 years old

You may not qualify if:

  • Patients unable to provide informed consent
  • Thyroid lymphoma
  • Metastases to the thyroid
  • No histological confirmed diagnosis
  • Only cytology available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden NHS Foundation Trust

London, Sutton, SM2 5PT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumour tissue for NGS panel testing. The tissue will be routinely processed formalin fixed paraffin embedded.

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Kate Newbold

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 26, 2017

First Posted

October 21, 2019

Study Start

December 21, 2015

Primary Completion

April 30, 2018

Study Completion

July 30, 2020

Last Updated

October 21, 2019

Record last verified: 2018-11

Locations

GB(1)