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Investigating Utility of ctDNA and Tumour Evolution in Advanced Thyroid Cancer

Sponsor: Royal Marsden NHS Foundation Trust

NCT ID: NCT05837260

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sample collection only (other)
How long the study runs
Study runs about 47 months (dates as stated)
About the drug or intervention
Sample collection only — other: Sample collection only
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
120
Started
2023-03-23
Last checked
2024-08

Plain English Summary

What is this study?

  • • Testing a new treatment for thyroid cancer
  • • Clinical study - 120 participants
  • • Although most thyroid cancers are treated and cured successfully there are still 30% who recur after many years

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with thyroid cancer

Where?

  • • London - The Royal Marsden NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Although most thyroid cancers are treated and cured successfully there are still 30% who recur after many years. This will eventually progress and at this point may become incurable with treatment options including complex and high risk surgery. The overall efficacy of systemic treatment in advanced thyroid cancer has a good initial response in most patients but not all. The study will collect tissues and blood samples for various protein analysis, nucleic acid extraction and live cell analysis in order to try and detect the presence of plasma ctDNA at baseline of eligible patients.

More detail

The treatment decisions are based on relying on radiological parameters such as using the RECIST criteria and measuring the rise in certain serum tumour biomarkers. However, the disadvantage of this is that this method can take many months to detect a change in disease volume. An improved understanding of genetics and cancer and potential gene sequencing can help achieve personalised treatment for patients. However, there are many questions and issues that still need to be answered and require urgent attention before being able to achieve optimate patient stratification. We need to identify better tumour biomarkers to detect disease progression, show real time response to treatment and understand why tumours evolve to becoming more aggressive. This study hopes to address these issues by proposing a multicentre prospective study to investigate the presence and role of ctDNA in advanced thyroid cancer including differentiated thyroid cancer , medullary thyroid cancer and Anaplastic Thyroid Cancer.

Thyroid Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Age 18 years or older. (all cohorts)
  • ✓Patients diagnosed with radioiodine refractory differentiated thyroid carcinoma (RR-DTC) under surveillance. (cohort 1)
  • ✓Patients with RR-DTC starting treatment that goes through your whole body Or Patients with RR-DTC on treatment that goes through your whole body Or Patients with MTC...
  • ✓Patients with newly diagnosed anaplastic thyroid cancer (cohort 4)
  • ✓Availability of tissue from one archival diagnostic tumour tissue block or be willing to have biopsy of accessible...

Who cannot take part

  • ✗Previous or concurrent illness, which in the investigator's opinion would interfere with collection of the complete...
  • ✗Any invasive cancer within previous 5 years (other than non-melanomatous skin carcinoma or carcinoma in situ)
  • ✗Pregnancy
See the full criteria
Inclusion Criteria: * Age 18 years or older. (all cohorts) * Patients diagnosed with radioiodine refractory differentiated thyroid carcinoma (RR-DTC) under surveillance. (cohort 1) * Patients with newly diagnosed resectable locally advanced medullary thyroid cancer Or Patients with newly diagnosed metastatic medullary thyroid cancer for surveillance Or Patients with locally advanced or metastatic medullary thyroid cancer on surveillance (cohort 2) * Patients with RR-DTC starting systemic therapy Or Patients with RR-DTC on systemic therapy Or Patients with MTC starting systemic therapy Or Patients with MTC on systemic therapy (cohort 3) * Patients with newly diagnosed anaplastic thyroid cancer (cohort 4) * Availability of tissue from one archival diagnostic tumour tissue block or be willing to have biopsy of accessible disease (all cohorts) * Patients must be willing to undergo standard monitoring and treatment as recommended by their clinical team (all cohorts) * Ability to give informed consent for biological sample collection. (all cohorts) Exclusion Criteria: * Previous or concurrent illness, which in the investigator's opinion would interfere with collection of the complete sample collection * Any invasive malignancy within previous 5 years (other than non-melanomatous skin carcinoma or carcinoma in situ) * Pregnancy

Where Is This Study? (1 UK site)

The Royal Marsden NHS Foundation Trust

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Leslie Cheng

Sponsor contact

CONTACT

02000000000 leslie.cheng@rmh.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-08