Investigating Utility of ctDNA and Tumour Evolution in Advanced Thyroid Cancer

Thyroid Cancer Clinical Trial

— NOMINATE  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837260
• Other study ID #: CCR5637
• Status: Recruiting
• Start date: March 23, 2023
• Est. completion date: February 7, 2027

Study information

• Verified date: May 2024
• Source: Royal Marsden NHS Foundation Trust
• Contact: Leslie Cheng
• Phone: 02000000000
• Email: leslie.cheng[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 7, 2027
• Est. primary completion date: February 7, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Other:
• Sample collection only
Sample collection only

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	5 years
Secondary	Specificity of the absence of plasma ctDNA in patients with advanced and recurrent thyroid cancer at baseline	Specificity of the absence of plasma ctDNA in patients with advanced and recurrent thyroid cancer at baseline	5 years
Secondary	Association of ctDNA levels as biomarker of disease burden compared with standard biochemical markers and radiological response	Association of ctDNA levels as biomarker of disease burden compared with standard biochemical markers and radiological response	5 years
Secondary	Changes in ctDNA levels as biomarker of disease burden compared with standard biochemical markers and radiological response	Changes in ctDNA levels as biomarker of disease burden compared with standard biochemical markers and radiological response	5 years
Secondary	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	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 years
Secondary	ctDNA as a biomarker of progression free and overall survival	ctDNA as a biomarker of progression free and overall survival	5 years