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NCT Number: NCT05837260

Investigating Utility of ctDNA and Tumour Evolution in Advanced Thyroid Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location status: Recruiting

Location contact

Leslie Cheng

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sample collection only

Other

Sample collection only

Primary outcomes

  1. The primary objective of the proposed study is to determine the sensitivity of detecting the presence of plasma ctDNA in patients with advanced and recurrent thyroid cancer

    Time frame: 5 years

    The primary objective of the proposed study is to determine the sensitivity of detecting the presence of plasma ctDNA in patients with advanced and recurrent thyroid cancer

Secondary outcomes

  1. Specificity of the absence of plasma ctDNA in patients with advanced and recurrent thyroid cancer at baseline

    Time frame: 5 years

    Specificity of the absence of plasma ctDNA in patients with advanced and recurrent thyroid cancer at baseline

  2. Association of ctDNA levels as biomarker of disease burden compared with standard biochemical markers and radiological response

    Time frame: 5 years

    Association of ctDNA levels as biomarker of disease burden compared with standard biochemical markers and radiological response

  3. Changes in ctDNA levels as biomarker of disease burden compared with standard biochemical markers and radiological response

    Time frame: 5 years

    Changes in ctDNA levels as biomarker of disease burden compared with standard biochemical markers and radiological response

  4. ctDNA as a biomarker of response to systemic therapy (levels and timing) compared with standard biochemical markers and radiological response in patients starting/during systemic therapy

    Time frame: 5 years

    ctDNA as a biomarker of response to systemic therapy (levels and timing) compared with standard biochemical markers and radiological response in patients starting/during systemic therapy

  5. ctDNA as a biomarker of progression free and overall survival

    Time frame: 5 years

    ctDNA as a biomarker of progression free and overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Leslie Cheng

CONTACT

[email protected]

02000000000

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study title

A Multicentre Prospective Study Investigating the Utility of ctDNA as a Biomarker of Disease Burden, Genetic Heterogeneity and Tumour Evolution in Advanced Thyroid Cancer

Acronym: NOMINATE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 1, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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